US20220199218A1 - Ambulatory medicament pump with integrated medicament ordering interface - Google Patents

Ambulatory medicament pump with integrated medicament ordering interface Download PDF

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Publication number
US20220199218A1
US20220199218A1 US17/654,776 US202217654776A US2022199218A1 US 20220199218 A1 US20220199218 A1 US 20220199218A1 US 202217654776 A US202217654776 A US 202217654776A US 2022199218 A1 US2022199218 A1 US 2022199218A1
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United States
Prior art keywords
medicament
subject
therapy
amd
user
Prior art date
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Abandoned
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US17/654,776
Inventor
Michael J. Rosinko
Himanshu Patel
Edward R. DAMIANO
Firas H. EL-KHATIB
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beta Bionics Inc
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Beta Bionics Inc
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Filing date
Publication date
Priority claimed from PCT/US2021/072742 external-priority patent/WO2022126080A1/en
Priority claimed from PCT/US2021/064228 external-priority patent/WO2022140204A1/en
Priority claimed from PCT/US2022/012795 external-priority patent/WO2022159393A1/en
Priority claimed from PCT/US2022/017368 external-priority patent/WO2022178447A1/en
Application filed by Beta Bionics Inc filed Critical Beta Bionics Inc
Priority to US17/654,776 priority Critical patent/US20220199218A1/en
Publication of US20220199218A1 publication Critical patent/US20220199218A1/en
Assigned to Beta Bionics, Inc. reassignment Beta Bionics, Inc. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DAMIANO, Edward R., EL-KHATIB, Firas H., ROSINKO, MICHAEL J., PATEL, HIMANSHU
Abandoned legal-status Critical Current

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Definitions

  • PCT/US2022/17368 is a continuation-in-part of PCT Application No. PCT/US2021/072742, filed Dec. 3, 2021, which claims priority to U.S. Provisional Patent Nos. 63/122,427, filed Dec. 7, 2020; 63/169,112, filed Mar. 31, 2021; 63/151,565, filed Feb. 19, 2021; 63/261,290, filed Sep. 16, 2021; 63/128,428, filed Dec. 21, 2020; 63/152,744, filed Feb. 23, 2021; 63/157,541, filed Mar. 5, 2021; 63/152,716, filed Feb. 23, 2021; 63/168,203, filed Mar. 30, 2021; 63/212,521, filed Jun.
  • PCT/US2022/17368 is a continuation-in-part of PCT Application No. PCT/US2021/064228, filed Dec. 17, 2021, which claims priority to U.S. Provisional Patent Nos. 63/128,428, filed Dec. 21, 2020; 63/167,563, filed Mar. 29, 2021; 63/216,177, filed Jun. 29, 2021; 63/239,365, filed Aug. 31, 2021; 63/169,112, filed Mar. 31, 2021; 63/151,565, filed Feb. 19, 2021; 63/261,290, filed Sep. 16, 2021; 63/152,744, filed Feb. 23, 2021; 63/157,541, filed Mar. 5, 2021; 63/152,716, filed Feb.
  • PCT/US2022/17368 is a continuation-in-part of PCT Application No. PCT/US2022/012795, filed Jan. 18, 2022 which claims priority to U.S. Provisional Patent Nos. 63/139,210, and filed Jan. 19, 2021; 63/238,670, filed Aug. 30, 2021.
  • the entire contents of each application referenced in this paragraph are hereby incorporated by reference herein for all purposes and made part of this specification. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.
  • This disclosure relates to glucose control systems, including medical devices that provide glucose control therapy to a subject, glucose level control systems, and ambulatory medicament pumps that deliver medicament to the subject to control glucose level in the subject.
  • Sustained delivery, pump driven medicament injection devices generally include a delivery cannula mounted in a subcutaneous manner through the skin of the subject at an infusion site.
  • the pump draws medicine from a reservoir and delivers it to the subject via the cannula.
  • the injection device typically includes a channel that transmits a medicament from an inlet port to the delivery cannula which results in delivery to the subcutaneous tissue layer where the delivery cannula terminates.
  • Some infusion devices are configured to deliver one medicament to a subject while others are configured to deliver multiple medicaments to a subject.
  • the medicament and/or supplies must be monitored and periodically replaced, which requires the subject keep track of the amount of medicament and/or supplies left. Failure to maintain an adequate supply of medicament and other supplies can disrupt treatment.
  • Such therapy reports may provide useful information for improving the quality of glucose control therapy provided to a group of subjects and/or reducing the cost glucose level control therapy.
  • Glucose level control system and ambulatory medical devices that provide therapy to a subject, such as glucose level control
  • Disclosed systems and devices can implement one or more features that improve the user experience, such as software update techniques that avoid interrupting delivery of therapy, gesture-based control of therapy delivery, automatic resumption of therapy after a user-initiated pause, improved alarm management, display of autonomously calculated dosing recommendations, wide area network connectivity, security features, automatically detecting when additional medicament and/or supplies (infusion sets, analyte sensors, transmitters, and/or other components) are needed, automatically prompting and/or facilitating the process for ordering additional medicament and supplies, modifying glucose control therapy remotely via a wireless connection, and allowing modification of glucose level control therapy based on requests received via voice/verbal commands.
  • additional medicament and/or supplies infusion sets, analyte sensors, transmitters, and/or other components
  • GLCSes glucose level control systems
  • the disclosed GLCSes may include interconnected remote computing systems, mobile electronic devices, and medicament delivery devices that cooperatively improve the glucose control therapy provided to a subject by facilitating various tasks associated with glucose therapy delivery, such as software update, controlling and modifying therapy delivery, monitoring and ordering supply and medicament.
  • the disclosed GLCSes may include automated systems that autonomously calculate dosing recommendations, monitor medicament and/or supplies, order additional medicament and/or supplies, and modify glucose control therapy.
  • some of the disclosed systems and methods can be implemented by a computing system to generate and share aggregate reports that include a summary of glucose control therapy provided to a group of subjects by the glucose level control systems or ambulatory medicament pumps, the resulting glycemic control of the subjects, comparative assessments, and evaluation of the therapy outcomes with respect to reference data and selected evaluation criteria.
  • Such therapy reports may be used to: evaluate a performance of the glucose level control systems, modify a control parameter of the glucose level control systems, evaluate the glycemic control of different groups of subjects receiving glucose control therapy from the same or different types of glucose level control systems, and any other assessment.
  • FIG. 1A illustrates an example glucose level control system that provides glucose level control via an ambulatory medicament pump.
  • FIG. 1B illustrates another example glucose level control system that provides glucose level control via an ambulatory medicament pump.
  • FIG. 1C illustrates a further example glucose level control system that provides glucose level control via an ambulatory medicament pump.
  • FIG. 2A shows a block diagram of an example glucose level control system.
  • FIG. 2B shows a block diagram of another example glucose level control system.
  • FIG. 2C shows a block diagram of another example glucose level control system.
  • FIG. 2D shows a block diagram of another example glucose level control system.
  • FIG. 3 is a schematic of an example glucose level control system that includes an electronic communications interface.
  • FIG. 4A shows a block diagram of an example glucose level control system in online operation mode.
  • FIG. 4B shows a block diagram of an example glucose level control system in offline operation mode.
  • FIG. 5A illustrates a perspective view of an example ambulatory medical device.
  • FIG. 5B illustrates a cross sectional view of the ambulatory medical device shown in FIG. 5A .
  • FIG. 6 illustrates different modules that may be included in an example ambulatory medical device.
  • FIG. 7 illustrates various methods and links that an ambulatory medical device (AMD) may establish a connection with a host computing system.
  • AMD ambulatory medical device
  • FIG. 8 is a flow diagram showing an example of a computer-implemented method that may be used by an AMD in order to detect and download an application update.
  • FIG. 9 is a flow diagram showing an example of a computer-implemented method that may be used by an AMD to install a down-loaded application update without interrupting the therapy provided to a subject.
  • FIG. 10 is a flow diagram showing an example of a computer-implemented method that may be used by an AMD to install a second update downloaded from a host computing system and switch control of the AMD from a first application to the second application without interrupting the therapy provided to a subject.
  • FIG. 11 is a flow diagram showing an example of a computer-implemented method that may be used by an AMD to install a second application downloaded from a host computing system, verify and switch control of the AMD from a first application to the second application without interrupting the therapy provided to a subject, only if the second application satisfies a minimum set of operation conditions.
  • FIG. 12 is a flow diagram showing an example of a computer-implemented method that may be used to respond to detection of an application fault during the execution of a first version of an application and switching control of the AMD to a second version an application installed on the AMD.
  • FIG. 13 is a flow diagram showing an example of a computer-implemented method that may be used to respond to detection of an application fault during the execution of a first version of an application and switching control of the AMD to a second version an application installed on the AMD and/or downloading a third version of the application.
  • FIG. 14 is a block diagram, illustrating an example network configuration wherein the AMD is directly connected to a computing system and the computing system shares the therapy reports with one or more display systems and the AMD.
  • FIG. 15 is a flow diagram illustrating an example method that may be used by a computing system, to generate and share a therapy report based on encrypted therapy data received from an AMD.
  • FIG. 16 is a block diagram, illustrating an example network and data flow configuration wherein the AMD is directly connected to a computing system and the computing system generates and sends alerts to one or more display systems and the AMD.
  • FIG. 17 is a flow diagram illustrating an example method that may be used by a computing system, to generate and send an alert to one or more authorized devices.
  • FIG. 18 illustrates the interconnection among modules and procedures in AMD involved in receiving, accepting and/or canceling therapy change request.
  • FIG. 19 is a flow diagram illustrating an example method that may be used by an AMD to allow a user to change the configuration of the ambulatory medicament device using a touch screen user interface.
  • FIG. 20A is an illustration of the touchscreen display of an example AMD after the touch screen is waked/unlocked by a wake action of a user and before the first user gesture is received.
  • FIG. 20B is an illustration of an example touchscreen display that may prompt the user to enter a predetermined series of inputs for the first gesture or second gesture.
  • FIG. 20C is an illustration of an example therapy change user interface.
  • FIG. 20D is an illustration of another therapy change user interface on a touchscreen display.
  • FIG. 21 is a flow diagram illustrating an example method that may be used by an AMD to generate an alarm status indicator.
  • FIG. 22 is a flow diagram illustrating an example method that may be used to cancel a therapy change using a touchscreen interface.
  • FIG. 23A is an illustration of a touchscreen display alerting the user that the delivery of one or more medicaments will occur.
  • FIG. 23B is an illustration of a touchscreen display showing that a medicament is being delivered to the user.
  • FIG. 24 is a block diagram illustrating the interconnection among modules and procedures in AMD involved in receiving, accepting and/or canceling a therapy suspension request.
  • FIG. 25 is a flow diagram illustrating an example method for receiving and implementing a suspension request, which may be implemented by an AMD.
  • FIG. 26 illustrates a plurality of screens that the ambulatory medical device may display when a user pauses therapy.
  • FIG. 27 is a flow diagram illustrating an example method of resuming a suspended therapy that may be implemented by an AMD.
  • FIG. 28 illustrates a plurality of screens that the ambulatory medical device may display when a user resumes therapy.
  • FIG. 29 is a block diagram illustrating the interconnection among modules and procedures in AMD involved in changing the settings of the AMD.
  • FIG. 30 is a flow diagram illustrating an example method that may be used by an AMD to allow a user to change a setting of the AMD using a user generated passcode or an override passcode.
  • FIG. 31 is a flow diagram illustrating an example method that may be used by an AMD to allow a user to change a setting of the AMD using a user generated passcode or an override passcode.
  • FIG. 32 is a schematic diagram illustrating the interconnection among modules and procedures in AMD involved in monitoring the status of the AMD and/or the subject and generate alarms when an alarm condition is met.
  • FIG. 33 is a flow diagram illustrating an example procedure that may be used by the alarm system of an AMD to annunciate an alarm condition upon receiving a status information that satisfies an alarm condition.
  • FIG. 34 is a block diagram illustrating the interconnection among modules and procedures in AMD involved in monitoring the condition of the AMD and generating alerts when a device malfunction is detected.
  • FIG. 35 is a flow diagram illustrating an example procedure that may be used by the alert system of an AMD to monitor the operation of an AMD and generate alerts when a device malfunction is detected.
  • FIG. 36 is a schematic diagram illustrating an ambulatory medical device that provides the user with various options for providing medicament.
  • FIG. 37 is a flow diagram of a process for providing options for meal dosage selection on an ambulatory device.
  • FIG. 38 is another flow diagram of a process for providing options for meal dosage selection on an ambulatory device.
  • FIG. 39 is a series of screen displays showing a user initiating the activation of meal dosage on an ambulatory device.
  • FIG. 40 is a series of screen displays showing a user activating meal dosage on an ambulatory device.
  • FIG. 41 is a series of screen displays showing a user activating meal announcement on an ambulatory device.
  • FIG. 42 is a series of screen displays showing a user inputting the total number of units on an ambulatory device.
  • FIG. 43 is a series of screen displays showing an ambulatory medical device delivering the units and cancelling the delivery of the units.
  • FIG. 44 is a schematic illustrating a computer system that can be implemented in various embodiments of the described subject matter.
  • FIG. 45 is a schematic illustrating an example ambulatory medicament pump that is configured to evaluate the need for additional supply of medicament and/or enable modification of glucose level control therapy delivered to a subject via a remote computing environment.
  • FIG. 46 is a flow chart flow diagram illustrating an example method that may be used by an AMD to determine an amount of total remaining medicament and/or to generate a user alert configured to indicate that additional supply of medicament may be necessary.
  • FIG. 47 is a flow chart flow diagram illustrating an example method that may be used by a medicament pump to modify glucose level control therapy delivered by an ambulatory medicament pump to a subject.
  • FIG. 48 is a flow chart flow diagram illustrating an example method that may be used by a remote therapy modification system to generate commands to remotely modify glucose level control therapy delivered to a subject by an ambulatory medicament pump.
  • FIG. 49 is a flow chart flow diagram illustrating an example method that may be used by a remote therapy modification system to modify glucose level control therapy delivered by an ambulatory medicament pump to a subject.
  • FIG. 50 shows a block diagram of another example glucose level control system.
  • FIG. 51 shows a method of automatically generating a user prompt with an infusion set ordering interface based on an estimate of remaining infusion sets falling below a reordering threshold.
  • FIG. 52 shows a method of automatically generating a user prompt with an analyte sensor ordering interface based on an estimate of remaining analyte sensors falling below a reordering threshold.
  • FIG. 53 shows a method of automatically generating a user prompt with a transmitter ordering interface based on an estimate of remaining transmitters falling below a reordering threshold.
  • FIG. 54 shows a method of monitoring a usage of infusion sets by an ambulatory medical device (e.g., ambulatory medicament pump) of a glucose level control system, transmitting data regarding the usage of infusion sets, and receiving a reordering message from a remote electronic device.
  • an ambulatory medical device e.g., ambulatory medicament pump
  • FIG. 55 shows a method of monitoring a usage of analyte sensors by an ambulatory medical device (e.g., ambulatory medicament pump) of a glucose level control system, transmitting data regarding the usage of analyte sensors, and receiving a reordering message from a remote electronic device.
  • an ambulatory medical device e.g., ambulatory medicament pump
  • FIG. 56 shows a method of monitoring a usage of transmitters by an ambulatory medical device (e.g., ambulatory medicament pump) of a glucose level control system, transmitting data regarding the usage of transmitters, and receiving a reordering message from a remote electronic device.
  • an ambulatory medical device e.g., ambulatory medicament pump
  • FIG. 57 illustrates a block diagram of an example system for generating aggregate reports based on therapy data received from a plurality of Glucose Level Control Systems (GLCSes) to a plurality of subjects, and sharing the aggregate reports with a display system.
  • GLCSes Glucose Level Control Systems
  • FIG. 58 illustrates a block diagram of an example computing system that generates an aggregate report based therapy data received from a plurality of GLCSes.
  • FIG. 59 shows an example aggregate report that generated by the computing system shown in FIG. 9 .
  • FIG. 60 is a flow diagram showing an example of a process for generating an aggregate report based on therapy data received from a plurality of GLCSes.
  • FIG. 61 is a flow diagram showing an example of a process for sharing an aggregate therapy report with a display system.
  • FIG. 62 is a flow diagram showing an example of a process for generating and sharing a customized aggregate therapy report in response to a customized report request received from a display system.
  • FIG. 63 is an example therapy administration system configured to manage glucose level control therapy delivered to a subject by an ambulatory medicament pump using a verbal command.
  • FIG. 64 shows a flow diagram illustrating an example method that may be used by a control system to manage glucose level control therapy delivered to a subject by an ambulatory medicament pump using a verbal command.
  • FIG. 65 shows a flow diagram illustrating an example method of controlling a therapy administration system when a verbal command is a specific command among various commands.
  • FIG. 66 shows a flow diagram illustrating an example method of controlling a therapy administration system when a verbal command is a medicament dose calculation command
  • FIG. 67 shows a flow diagram illustrating an example method of controlling a therapy administration system for authenticating a user based on a verbal command.
  • FIG. 68 shows a flow diagram illustrating an example method of controlling a therapy administration system when an alert signal is generated.
  • FIG. 69 shows a flow diagram illustrating an example method of controlling a therapy administration system when a verbal command includes an abort command.
  • FIG. 70 shows an example system configured to manage execution of a command by an ambulatory medicament pump using a verbal command.
  • FIG. 71 shows a flow diagram illustrating an example method of managing execution of a verbal command by an ambulatory medicament pump.
  • FIG. 72 shows a flow diagram illustrating an example method of managing execution of a verbal command to identify an ambulatory medicament pump for receiving a verbal command.
  • FIG. 73 shows a flow diagram illustrating an example method managing execution of a verbal command for authenticating a user based on a verbal command.
  • FIG. 74 shows a flow diagram illustrating an example method of controlling a therapy administration system when a user is authenticated.
  • FIG. 75 shows a flow diagram illustrating an example method of controlling a verbal command execution system when a verbal command is a specific command among various commands.
  • FIG. 76 shows a flow diagram illustrating an example method of controlling a therapy administration system when a verbal command is a medicament dose calculation command.
  • FIG. 77 shows a flow diagram illustrating another example method of controlling a therapy administration system when a verbal command is a medicament dose calculation command.
  • FIG. 78 Shows a flow diagram illustrating an example method of controlling a therapy administration system when there is an alert signal.
  • FIG. 79 is a schematic illustrating an example ambulatory medicament pump that is configured to transmit a request to modify glucose level control therapy delivered to a subject via a verbal command.
  • FIG. 80 shows a flow diagram illustrating an example method of controlling an ambulatory medicament pump of FIG. 79 to execute a glucose level control system command.
  • FIG. 81 shows a flow diagram illustrating an example method of controlling a therapy administration system when there is an alert signal.
  • FIG. 82 is a diagram illustrating an example verbal command for modifying glucose level control therapy delivered.
  • FIG. 83 shows a flow diagram illustrating an example method of controlling an ambulatory medicament pump when a verbal command is a medicament dose calculation command.
  • FIG. 84 is a diagram illustrating an exemplary connection relationship between each system for verbal communication, a medicament pump, and a user interface.
  • Some embodiments described herein pertain to medicament infusion systems for one or more medicaments and the components of such systems (e.g., infusion pumps, medicament cartridges, cartridge connectors, lumen assemblies, infusion connectors, infusion sets, etc.). Some embodiments pertain to methods of manufacturing infusion systems and components thereof. Some embodiments pertain to methods of using any of the foregoing systems or components for infusing one or more medicaments (e.g., pharmaceutical, hormone, etc.) to a subject.
  • an infusion system may include an infusion pump, which can include one or more medicament cartridges or can have an integrated reservoir of medicament.
  • An infusion system may include medicament cartridges and cartridge connectors, but not a pump.
  • An infusion system may include cartridge connectors and an infusion pump, but not medicament cartridges.
  • An infusion system may include infusion connectors, a lumen assembly, cartridge connectors, an infusion pump, but not medicament cartridges or an infusion set.
  • a glucose level control system can operate in conjunction with an infusion system to infuse one or more medicaments, including at least one glucose level control agent, into a subject.
  • An infusion system may include a user interface that allow modifying one or more control parameters that control medicament delivery to a subject.
  • An infusion system may include a wireless transceiver that allows data communication between the infusion system and one or more electronic devices.
  • Some embodiments described herein pertain to computing systems for generating aggregate reports.
  • a computing system e.g., a computing system in patient data network
  • the computing system may request and receive the therapy data via data connections (e.g., wireless data connections) established with the GLCSes.
  • the computing system may include an electronic processor, a memory that stores machine readable instructions usable by the electronic processor, and reference data associated with glycemic control of a subject and/or performance of a GLCS.
  • the processor may process the received therapy data to generate aggregate therapy data, determine the values of one or more biometric parameters, and to generate a comparative assessment and an evaluation using the reference data, aggregate therapy data and aggregate biometric data.
  • the computing system generates an aggregate report that may include representations (e.g., graphical and/or textual representations) of the aggregate therapy data, the aggregate biometric data, the comparative assessment, and the evaluation.
  • the computing system may share the aggregate report with a display system in response to receiving a report request.
  • the computing system may generate and share a customized aggregate report with a display system upon receiving a customized report request.
  • Any feature, structure, component, material, step, or method that is described and/or illustrated in any embodiment in this specification can be used with or instead of any feature, structure, component, material, step, or method that is described and/or illustrated in any other embodiment in this specification. Additionally, any feature, structure, component, material, step, or method that is described and/or illustrated in one embodiment may be absent from another embodiment.
  • a glucose level control system is used to control glucose level in a subject.
  • glucose level may comprise blood glucose level, or glucose level in other parts of fluids on subjects body.
  • glucose level may comprise a physiological glucose level of the subject that can be a concentration of glucose in subject's blood or an interstitial fluid in part of the subject's body (e.g., expressed in milligram per deciliter (mg/dl)).
  • Glucose level control systems (GLCSes) or glucose control systems which are sometimes referred to herein as glucose level systems, can include a controller configured to generate dose control signals for one or more glucose control agents that can be infused into the subject.
  • Glucose control agents can be delivered to a subject via subcutaneous injection, via intravenous injection, or via another suitable delivery method. In the case of glucose control therapy via an ambulatory medicament pump, subcutaneous injection is most common.
  • Glucose control agents may include regulatory agents that tend to decrease a glucose level (e.g., blood glucose level) of the subject, such as insulin and insulin analogs, and counter-regulatory agents that tend to increase a glucose level of the subject, such as glucagon or dextrose.
  • a glucose level control system configured to be used with two or more glucose control agents can generate a dose control signal for each of the agents. In some embodiments, a glucose level control system can generate a dose control signal for an agent even though the agent may not be available for dosing via a medicament pump connected to the subject.
  • a GLCS may include or can be connected to an ambulatory medicament pump (AMP).
  • An ambulatory medicament pump is a type of ambulatory medical device (“AMD”), which is sometimes referred to herein as an ambulatory device, an ambulatory medicament device, or a mobile ambulatory device.
  • ambulatory medical devices include ambulatory medicament pumps and other devices configured to be carried by a subject and to deliver therapy to the subject. Multiple AMDs are described herein. It should be understood that one or more of the embodiments described herein with respect to one AMD may be applicable to one or more of the other AMDs described herein.
  • a GLCS can include a therapy administration system and an AMD that is in communication with the therapy administration system.
  • the AMD may comprise an AMP.
  • a GLCS implements algorithms and medicament or glucose control functionality discussed herein to provide medicament or glucose control therapy without being connected to an AMD.
  • the GLCS can provide instructions or dose outputs that direct a user to administer medicament to provide glucose control therapy.
  • the user may use, for example, a medicament pen to manually or self-administer the medicament according the GLCS's dose outputs.
  • the user may also provide inputs such as glucose level readings into the GLCS for the GLCS to provide dose outputs.
  • the user inputs into the GLCS may be in combination with inputs from other systems or devices such as sensors as discussed herein.
  • the GLCS can provide glucose control therapy based on user inputs without other system or device inputs.
  • the GLCS includes a memory that stores specific computer-executable instructions for generating a dose recommendation and/or a dose control signal.
  • the dose recommendation and/or the dose control signal can assist with glucose level control of a subject via medicament therapy.
  • the dose recommendation or dose output of the GLCS can direct a user to administer medicament to provide medicament therapy for glucose level control, including manual administration of medicament doses.
  • the GLCS includes the memory and a delivery device for delivering at least a portion of the medicament therapy.
  • the GLCS includes the memory, the delivery device, and a sensor configured to generate a glucose level signal. The GLCS can generate the dose recommendation and/or the dose control signal based at least in part on the glucose level signal.
  • control parameters can include subject-specific parameters, delivery device-specific parameters, glucose sensor-specific parameters, demographic parameters, physiological parameters, other parameters that can affect the glucose level of the subject, or any combination of one or more of the foregoing.
  • the ambulatory medical device is an electrical stimulation device
  • therapy delivery includes providing electrical stimulation to a subject.
  • An example of an electrical stimulation device is a cardiac pacemaker.
  • a cardiac pacemaker generates electrical stimulation of the cardiac muscle to control heart rhythms.
  • Another example of an electrical stimulation device is a deep brain stimulator to treat Parkinson's disease or movement disorders.
  • FIG. 1A - FIG. 1C show examples of glucose level control systems that provide glucose level control via an ambulatory medical device or AMD, such as an ambulatory medicament pump (AMP), connected to a subject.
  • AMD ambulatory medical device
  • AMP ambulatory medicament pump
  • the AMD 100 is connected to an infusion site 102 using an infusion set 104 .
  • the AMD 100 may include a medicament pump and an integrated user interface 106 a that permit a user to view pump data and change therapy settings via user interaction with the user interface elements of the user interface 106 a .
  • An analyte sensor 110 such as a glucose level sensor, generates a glucose level signal that is received by the glucose level control system.
  • the analyte sensor 110 can include an insulin level sensor that can generate an insulin level signal that can be received by the glucose level control system.
  • the analyte senor 110 can include a glucose level sensor and/or an insulin level sensor.
  • the analyte senor 110 may include a continuous glucose monitor (CGM).
  • CGM continuous glucose monitor
  • the glucose level control system includes the AMD 100 (e.g., an medicament pump) communicates with an external electronic device 108 (such as, for example, a smartphone) via a wireless data connection. At least some of the pump controls can be manipulated via user interaction with user interface elements in the user interface 160 b of the external electronic device 108 .
  • the glucose level sensor 110 can also communicate with the AMD 100 (that includes a medicament pump) via a wireless data connection.
  • the AMD 100 (e.g., a medicament pump) includes an integrated cannula that inserts into the infusion site 102 without a separate infusion set.
  • the pump controls can be manipulated via user interaction with user interface elements 106 b of an external electronic device 108 .
  • pump controls can be manipulated via user interaction with user interface elements generated by a remote computing environment (not shown), such as, for example, a cloud computing service, that connects to the AMD 100 (medicament pump) via a direct or indirect electronic data connection.
  • Glucose level control systems typically include a user interface configured to provide one or more of therapy information, glucose level information, and/or therapy control elements capable of changing therapy settings via user interaction with interface controls.
  • the user can provide an indication of the amount of the manual bolus of medicament from an electronic device remote from the medicament pump.
  • the user interface can be implemented via an electronic device that includes a display and one or more buttons, switches, dials, capacitive touch interfaces, or touchscreen interfaces, or voice interfaces.
  • at least a portion of the user interface is integrated with an ambulatory medicament pump that can be tethered to a body of a subject via an infusion set configured to facilitate subcutaneous injection of one or more glucose control agents.
  • at least a portion of the user interface is implemented via an electronic device separate from the ambulatory medicament pump, such as a smartphone.
  • FIG. 2A - FIG. 2D illustrate block diagrams showing example configurations of four different embodiments ( 200 a / 200 b / 200 c / 200 d ) of a glucose level control system.
  • a glucose level control system 200 a may comprise an ambulatory medical device (AMD) 100 that includes a controller 202 a having an electronic processor 204 a and a memory 210 a that stores instructions 208 a executable by the electronic processor 204 a .
  • the controller 202 a and a pump 212 e.g., a medicament pump
  • the pump 212 can be an infusion pump for administering regulatory agent and/or counter-regulatory agent.
  • the AMD 100 can include at least one pump 212 .
  • the AMD 100 may include at least one pump and a wireless connection interface or a transceiver.
  • the AMD 100 can include a wireless electronic communications interface (e.g., the transceiver 214 a ) for wireless data (e.g., digital data) communications with external electronic devices.
  • the controller 202 a can implement at least a portion of a control algorithm that generates dose control signals for one or more glucose control agents based on time-varying glucose levels of the subject (e.g., received from a glucose level sensor 110 that is in communication with the AMP 100 ) and one or more control parameters.
  • the dose control signals when delivered to the pump 212 , result in dosing operations that control a glucose level of the subject.
  • the pump 212 may be controlled by at least one pump controller. In some examples, the pump controller may be included in the pump 212 .
  • the pump controller receives the dose control signals and controls the operation of the pump 212 based on the received dose control signals.
  • the pump controller may be integrated with the pump.
  • the controller may be included in the AMP 100 , or in an external electronic device 108 or a remote computer 206 , that are connected to the AMP 100 via wired or wireless communication links.
  • a glucose level control system may comprise an ambulatory medicament pump AMP 100 (also referred to as ambulatory medicament pump or AMP) that includes a medicament pump, and at least one controller that controls the medicament pump.
  • the controller may be included in the AMD 100 , or in an external electronic device 108 or a remote computer 206 , that are connected to the AMD 100 via wired or wireless communication links.
  • a glucose level control system 200 b can operate at least partially via execution of instructions 208 b by an electronic processor 204 b of an external electronic device 108 separate from the AMD 100 .
  • the external electronic device 108 can include a transceiver 214 b capable of establishing a wireless data connection to the AMD 100 , and a controller 202 b can implement at least a portion of a control algorithm via execution of instructions 208 b stored in memory 210 b .
  • the controller 202 b can implement at least a portion of a control algorithm that generates dose control signals for one or more glucose control agents based on time-varying glucose levels of the subject and one or more control parameters.
  • the dose control signals when delivered to the pump controller of the pump 212 , result in dosing operations that control the glucose level of a subject.
  • the dose control signals are transmitted from the electronic device transceiver 214 b to the AMD transceiver 214 a over a short-range wireless data connection 216 .
  • the AMD 100 receives the dose control signals and passes them to the pump controller of the pump 212 for dosing operations.
  • a glucose level control system 200 c may include a remote computer 206 that is in communication with the AMD 100 (e.g., an ambulatory medicament pump).
  • the glucose level control system 200 c can operate at least partially via execution of instructions 208 c by an electronic processor 204 c integrated with the remote computer 206 , such as, for example, a cloud service (e.g., remote computing environment).
  • the controller 202 c can implement at least a portion of a control algorithm that generates dose control signals for one or more glucose control agents based on time-varying glucose levels of the subject and one or more control parameters.
  • the dose control signals when received by the pump controller of the pump 212 , may result in dosing operations that control the glucose level of a subject.
  • the dose control signals are transmitted from the remote computer 206 from wide area network (WAN) connection interface of the remote computer 206 (e.g., WAN connection interface 220 c ) to a WAN connection (e.g., WAN connection interface 220 a ) of the AMD 100 over an end-to-end wireless data connection 218 .
  • WAN wide area network
  • the AMD 100 receives the dose control signals and passes them to the pump 212 (or the controller that controls the pump 212 ) for dosing operations.
  • a glucose level control system 200 d that includes a remote computer 206 that is in communication with an external electronic device 108 (e.g., an electronic device of the subject), and the AMD 100 , which is in communication with the electronic device 108 .
  • the glucose level control system 200 d can have two or more controllers 202 a , 202 b , 202 c (e.g., located in different subsystems) that cooperate to generate a dose control signal for dosing operations by the pump 212 .
  • the remote computer 206 can transmit or receive data or instructions passed through a WAN connection interface 220 c via an end-to-end wireless data connection 218 to a WAN connection interface 220 b of the external electronic device 108 .
  • the external electronic device 108 can transmit or receive data or instructions passed through a transceiver 214 b via a short-range wireless data connection 216 to a transceiver 214 a of an AMD 100 .
  • the electronic device 108 can be omitted, and the controllers 202 a , 202 c of the AMD 100 and the remote computer 206 cooperate to generate dose control signals that are passed to the pump 212 (or the pump controller that controls pump 212 ).
  • the AMD 100 may have its own WAN connection interface to support a direct end-to-end wireless data connection to the remote computer 206 .
  • a glucose control system 200 may include circuitry that implements an electronic communications interface (ECI) 302 configured to send and receive electronic data from one or more electronic devices.
  • ECI includes a sensor interface 304 (e.g., a glucose sensor interface) configured to receive a glucose level signal from a sensor 110 (e.g., an analyte sensor or a glucose level sensor) such as a continuous glucose monitor (CGM).
  • a sensor 110 e.g., an analyte sensor or a glucose level sensor
  • CGM continuous glucose monitor
  • the sensor 110 can be a continuous glucose monitor (CGM).
  • Some CGMs may generate glucose level signals at fixed or periodic measurement intervals, such as five-minute intervals.
  • the sensor 110 can be operatively connected to a subject in order to generate a glucose level signal that corresponds to a glucose level estimate or measurement of the subject.
  • the glucose level signal can be used by the controller 202 a to generate a dose control signal.
  • the dose control signal can be provided to a pump 212 via a pump interface 306 (or a delivery device interface).
  • the sensor interface 304 connects to the sensor 110 via a short-range wireless connection 308 .
  • the pump interface 306 connects to the pump 212 via a short-range wireless connection 310 .
  • the pump interface 306 connects to the pump 212 via a local data bus, such as when the controller 202 a , the ECI 302 , and the pump 212 are integrated into an AMD 100 .
  • the sensor 110 can be an insulin level sensor that can detect insulin levels.
  • the sensor interface 304 can be configured to receive an insulin level signal from the sensor 110 , which can correspond to an insulin level estimate or measurement of the subject (e.g., a concentration of insulin in subject's blood).
  • the insulin level signal can be used by the controller 202 a to generate a dose control signal, which can be provided to the pump 212 via the pump interface 306 .
  • the sensor 110 can include a glucose sensor and an insulin sensor.
  • the controller 202 a can be configured to generate the dose control signal using a control algorithm that generates at least one of a basal dose, a correction dose, and/or a meal dose (or food intake). Examples of some control algorithms that can be used to generate these doses are disclosed in U.S. Patent Application Publication Nos. 2008/0208113, 2013/0245547, 2016/0331898, and 2018/0220942 (referenced herein as the “Controller Disclosures”), or in the PCT Patent Application Publication No. WO 2021/067856, the entire contents of which are incorporated by reference herein and made a part of this specification.
  • the correction dose can include regulatory or counter-regulatory agent and can be generated using a model-predictive control (MPC) algorithm and/or other algorithms such as those disclosed in the Controller Disclosures.
  • the basal dose can include regulatory agent and can be generated using a basal control algorithm such as disclosed in the Controller Disclosures.
  • the meal dose can include regulatory agent and can be generated using a meal control algorithm such as disclosed in the Controller Disclosures. In some cases, a meal dose can be generated by the subject via a user interface of the glucose level control system 200 a / 200 b / 200 c / 200 d . Additional aspects and improvements for at least some of these controllers are disclosed herein.
  • the dose control signal can be transmitted to pump interface 306 via the ECI 302 or can be transmitted to the pump interface 306 via an electrical conductor when the controller 202 a is integrated in the same housing as the pump interface 306 .
  • FIG. 4A shows a block diagram of an example glucose level control system in online operation mode.
  • the controller 400 can be configured to operate in “online mode” (or “automatic mode”) during time periods when the controller 400 receives a glucose level signal 402 from the sensor 110 (e.g., a glucose level sensor) and/or an insulin level signal 402 from the sensor 110 (e.g., an insulin level sensor).
  • the control algorithm In online mode, the control algorithm generates a dose control signal 404 that implements regular correction doses based on values of the glucose level signal 402 and/or insulin level signal 402 and control parameters of the control algorithm.
  • the pump 212 is configured to deliver at least correction doses and basal doses to the subject without substantial user intervention while the controller 400 remains in online mode.
  • the ambulatory medicament pump 212 can include one or more medicament cartridges or can have an integrated reservoir 408 of medicament.
  • the reservoir 408 may be integrated with the pump 212 .
  • a medicament stored in the reservoir 408 can be delivered to the subject by operation of the pump 212 .
  • the operation of the pump 212 can be controlled by the controller 400 .
  • the controller 400 may generate the dose control signal 404 using a control scheme such as described in U.S. Pat. No. 7,806,854, the contents of which are hereby incorporated by reference in its entirety herein.
  • FIG. 4B shows a block diagram of an example glucose level control system in offline operation mode.
  • the controller 400 can be configured to operate in “offline mode” during time periods when the controller does not receive a glucose level signal 402 and/or insulin level signal 402 from a sensor 110 , at least during periods when the glucose level signal 402 is expected but not received.
  • the controller may generate dose control signals as described in U.S. Pat. No. 10,543,313, the entire contents of which are hereby incorporated by reference in its entirety herein.
  • the control algorithm In offline mode, the control algorithm generates a dose control signal 404 that implements correction doses in response to isolated glucose measurements 406 (such as, for example, measurements obtained from the subject using glucose test strips) and/or insulin measurements 406 and based on control parameters of the control algorithm.
  • the pump 212 is configured to deliver basal doses to the subject without substantial user intervention and can deliver correction doses to the subject in response to isolated glucose measurements 406 and/or isolated insulin measurements 406 while the controller 400 remains in offline mode.
  • the ambulatory medical device can be a portable or wearable device (e.g., an insulin or bi-hormonal medicament pump) such as an ambulatory medicament pump (AMP) that provides life-saving treatment to a subject by delivering one or more medicaments (e.g., insulin and/or glucagon) to a subject.
  • a portable or wearable device e.g., an insulin or bi-hormonal medicament pump
  • AMP ambulatory medicament pump
  • Some AMDs may continuously monitor the health condition of a subject (e.g., glucose level, insulin level, heart rate, etc.) using a sensor (e.g., a glucose level sensor that can measure values corresponding to the glucose level, or a blood insulin level sensor that can measure values corresponding to the blood insulin level, etc.) and deliver therapy (e.g., one or more medicaments) to the subject based on the health condition of the subject.
  • a sensor e.g., a glucose level sensor that can measure values corresponding to the glucose level, or a blood insulin level sensor that can measure values corresponding to the blood insulin level, etc.
  • therapy e.g., one or more medicaments
  • an AMP e.g., an insulin pump or a bi-hormonal pump
  • CGM Continuous Glucose Monitor
  • Certain AMDs may be worn by subjects constantly (e.g., all day), or for a large portion of the day (e.g., during waking hours, during sleep hours, when not swimming, etc.) to enable continuous monitoring of the health condition of the subject and to deliver medicament as necessary.
  • an AMD may be an ambulatory medicament device such as a medicament delivery pump.
  • an AMD may be a device that provides therapy in the form of electrical stimulation based on a health condition of a subject (e.g., heart rhythm or brain activity) determined using signals received from one or more sensors (e.g., heartbeat monitor or electrodes monitoring activity of the brain).
  • FIG. 5A illustrates a three-dimensional (3D) view of an example ambulatory medical device 500 (such as an ambulatory medicament pump) comprising a housing 502 with a wake button 506 and a touchscreen display 504 .
  • FIG. 5B is an illustration of a cross sectional view of the ambulatory medical device 500 shown in FIG. 5A .
  • all the electronic systems 508 are included inside the housing, for example, as a single integrated electronic board.
  • the wake button 506 may be any type of button (e.g., capacitive, inductive, resistive, mechanical, etc.) that registers an input generated by user interaction with the wake button 506 to generate a wake signal.
  • a wake signal may be a signal that activates a user interface of the AMP (e.g., a touchscreen display).
  • the wake button 506 if touched, pressed, or held for a period, may generate the wake signal that activates the touchscreen display 504 .
  • the wake signal is generated by a sensor (e.g., a biometric sensor such as a fingerprint reader or a retinal scanner, an optical or RF proximity sensor, and the like).
  • the wake signal may be generated by user interaction with the touch screen display 504 or with an alphanumeric pad (not shown).
  • wake signal may be generated based on facial recognition or other biometric indicia.
  • the wake signal may be generated by a wireless signal such as a signal generated by an RFID system or Bluetooth signals received from an electronic device or by detection of movement using one or more motion sensors such as an accelerometer.
  • the wake button 506 if touched, pressed, or held for a certain period of time, may generate a wake signal that activates the touchscreen display 504 .
  • touches on the touchscreen display 504 are not registered until the wake button activates the touchscreen display.
  • the AMD remains locked from accepting at least certain types of user interaction or settings modification until a gesture (such as, for example, any of the gesture interactions described with reference to any of the embodiments disclosed herein) is received after the touchscreen display 504 is activated by the wake button 506 .
  • a passcode may be required to unlock the touchscreen display.
  • the AMD 500 includes a microphone and a speaker for receiving a sound (e.g., user's voice) and outputting a sound, respectively. In this case, a user can wake up the touchscreen by a voice input.
  • FIG. 6 illustrates different modules or systems that may be included in an example ambulatory medicaments device (AMD) or an example glucose level control system (GLCS).
  • the AMD (or GLCS) 600 may comprise a complete glucose level control system (e.g., glucose level control system 200 a / 200 b / 200 c / 200 d ), or can include one or more components of a complete glucose level control system (e.g., a medicament pump, a transceiver, and/or a controller).
  • a complete glucose level control system e.g., glucose level control system 200 a / 200 b / 200 c / 200 d
  • a complete glucose level control system e.g., a medicament pump, a transceiver, and/or a controller.
  • the AMD 600 may include one or more modules or systems that can facilitate monitoring a subject's glucose level (e.g., glucose level in an interstitial fluid of the subject, or subject's glucose level), monitoring a subject's insulin level, managing the subject's diabetes, tracking a condition of the AMD 600 , tracking usage of infusion sets, tracking usage of analyte sensors, and/or communicating with one or more computing systems (e.g., remote computing systems).
  • the AMD (or GLCS) 600 may include a mono-hormonal or bi-hormonal medicament pump configured to administer one or more types of insulin and, in some cases, counter-regulatory agent (e.g., Glucagon or other medicament that can reduce or address hypoglycemia).
  • the AMD 600 may include one or more alarm generators, transceivers, touchscreen controllers, display controllers, encryption modules, etc.
  • two or more of the modules or systems may be integrated together inside a single housing 502 (as shown in FIGS. 5A and 5B ).
  • one or more modules may be individual modules contained in separate housings that communicate with other modules and/or the main unit via a wired or wireless communication link (e.g., Bluetooth).
  • the modules included in the AMD 600 may include a communication module 602 , signal processing module 604 , a medicament delivery or therapy delivery module 606 , a user interface module 608 , and a control and computing module (CCM) 610 .
  • CCM control and computing module
  • control and computing module 610 can be the same or similar in at least some respects to the other glucose control system controllers described herein, including, for example, the controllers 202 a - c , and 400 described with reference to FIGS. 2A-D and 4 A-B.
  • one or more modules may comprise one or more single purpose or multipurpose electronic systems. In some such examples, one or more electronic systems may perform procedures associated with different features of the AMD 600 .
  • one or more modules or systems may comprise a non-transitory memory that stores machine readable instructions and a processor that executes instructions stored in the memory.
  • the memory may be a non-volatile memory, such as flash memory, a hard disk, magnetic disk memory, optical disk memory, or any other type of non-volatile memory. Further, types of memory may include but are not limited to random access memory (“RAM”) and read-only memory (“ROM”). In some such examples, a system can be programed to perform different procedures each implemented based on a different set of instructions.
  • RAM random access memory
  • ROM read-only memory
  • the therapy delivery module 606 may be an external medicament delivery system that is in communication with the control and computing module 610 , e.g., via the communication module 602 (e.g., via a wired or wireless link).
  • the therapy delivery module 606 may be included in the same housing as other systems and subsystems of the AMD 600 .
  • AMD 600 may include a therapy delivery interface configured to transmit dose control signals to the external therapy delivery system and receive signals indicating the status of the external therapy delivery system and/or medicament delivery.
  • the therapy delivery interface may be included in the communication module 602 .
  • the external therapy delivery module may communicate with the AMD 600 using a wireless transceiver included in the external therapy delivery module.
  • the control and computing module 610 may include one or more processors 614 , a main memory 616 , a storage 618 that may comprise one or more non-transitory and/or non-volatile memories and an interface 612 that enables data and signal communication among the systems within the control and computing module 610 as well as communication between the control and computing module 610 and all other modules of the AMD 600 .
  • the main memory 616 and the storage 618 each may be divided into two or more memory locations or segments.
  • the main memory 616 may communicate with the other components of the control and computing module 610 as well as other modules via the interface 612 . Instructions may be transmitted to the main memory (e.g., from the storage) and the processor 614 may execute instructions that are communicated to the processor through the main memory 616 .
  • the storage 618 may store data while the control and computing module 610 is powered or unpowered.
  • the storage 618 may exchange data with sub-systems within the control and computing module 610 as well as other systems (e.g., via the interface 606 ).
  • the storage 618 may exchange data with the main memory directly or through the interface 612 .
  • the main memory 616 can be any type of memory that can store instructions and communicate them to the processor 614 and receive executed instructions from the processor 614 . Types of main memory include but are not limited to random access memory (“RAM”) and read-only memory (“ROM”).
  • the processor 614 may be any type of general purpose central processing unit (“CPU”).
  • control and computing module may include more than one processor of any type including, but not limited to complex programmable logic devices (“CPLDs”), field programmable gate arrays (“FPGAs”), application-specific integrated circuits (“ASICs”) or the like.
  • the storage 618 can be any type of computer storage that can receive data, store data, and transmit data to the main memory 616 and possibly other modules of AMD 600 .
  • Types of storage 618 that can be used in the control and computing module 610 include, but are not limited to, magnetic disk memory, optical disk memory, flash memory and the like.
  • the interface 612 may include data transfer buses and electronic circuits configured to support data exchange among different components within the control and computing module 610 . In some examples, in addition to data exchange between any of the systems and the control and computing module 610 , the interface 612 may also support data and signal exchange among other modules as well as data exchange between any of the modules and the control and computing module 610 .
  • the signal processing module 604 may include a plurality of interconnected electronic modules for signal conditioning and signal conversion (e.g., A-to-D or ADC conversion and D-to-A conversion of DAC conversion) configured to support communication and data exchange between different modules.
  • the signal processing module 604 may convert an analog signal received from the communication module 602 and convert it to a digital signal that can be transmitted to the control and computing module 610 (e.g., via the interface 612 ).
  • the control and computing module 610 may further process the digital signal and control one or more modules based on the processed signal.
  • the signal processing module 604 may receive a digital control signal from the control and computing module 610 and convert it to a dose control signal (e.g., an analog signal) that can be transmitted to the therapy delivery module 606 , for example, to control one or more infusion pumps included in the therapy delivery module 606 .
  • a dose control signal e.g., an analog signal
  • the therapy delivery module 606 may comprise one or more infusion pumps configured to deliver one or more medicaments (e.g., insulin, glucagon, etc.) to a subject 622 and a pump controller that may activate the infusion pumps upon receiving dose control signals.
  • the medicaments may be stored in one or more medicament cartridges housed in the therapy delivery module 606 .
  • the medicaments may be stored in a cavity of the therapy delivery module 606 or in a cartridge inserted in a cartridge receptacle of the therapy delivery module 606 .
  • the therapy delivery module 606 may include electronic and mechanical components configured to control the infusion pumps based on the signals received from control and computing module 610 (e.g., via the signal processing module 604 or the interface 612 ). In some examples, the therapy delivery module 606 may include a pump controller that controls the infusion pumps upon receiving dose control signals from the control and computing module 610 .
  • the user interface module 608 may include a display to show various information about the AMD 600 , for example, medicament type and delivery schedule, software status, and the like.
  • the display may show graphical images and text using any display technology including, but not limited to OLED, LCD, or e-ink.
  • the AMD 600 may include a user interface (e.g., an alphanumeric pad) that lets a user enter information or interact with the AMD 600 to modify the settings of the AMD 600 , respond or submit to request(s) for certain actions (e.g., ordering infusion sets, sensors, transmitters, replacement components, a replacement pump, etc.) and the like.
  • the alphanumeric pad may include a multitude of keys with numerical, alphabetical, and symbol characters.
  • the keys of the alphanumeric pad may be capacitive or mechanical.
  • the user may be a subject 622 receiving medicament or therapy, or may be another user, such as a clinician or healthcare provider, or a parent or guardian of the subject 622 .
  • the AMD 600 may include a touchscreen display that produces output and also accepts input enabling a two-way interaction between the user and the AMD 600 .
  • the touchscreen display may be any input surface that shows graphic images and text and also registers the position of touches on the input surface.
  • the touchscreen display may accept input via capacitive touch, resistive touch, or other touch technology.
  • the input surface of the touchscreen display can register the position of touches on the surface. In some examples, the touchscreen display can register multiple touches at once.
  • the keypad may be a display of a keypad.
  • an alphanumeric pad comprising user-selectable letters, numbers, and symbols may be displayed on the touchscreen display.
  • the touchscreen may present one or more user-interface screens (e.g. as described in reference to FIGS. 50-52 ) to a user enabling the user to modify one or more therapy settings of the ambulatory medicament device, order additional infusion sets, order additional analyte sensors, order a replacement AMD, etc.
  • a user-interface screen may comprise one or more parameter control elements.
  • a user-interface screen may include one or more user input elements displayed on the screen that enable a user to interact with the AMD 600 .
  • a user-interface screen may comprise one or more therapy control elements (e.g., displayed on the touchscreen display) enabling a user or the subject to access therapy change controls and modify therapy settings by interacting with these control elements. For example, the user can modify the therapy settings by changing one or more control parameters using the corresponding therapy control elements.
  • a therapy control parameter comprise any parameter that controls or affects the volume, duration and/or the frequency of medicament doses delivered to the subject.
  • the user interface module 608 may include an audio or auditory sensor and system such as a speaker and a microphone for voice recognition.
  • a user can verbally interact with the AMD 600 without contacting the device.
  • the verbal interaction may reduce gesture motion of the user for controlling the AMD 600 .
  • “voice recognition” refers to identifying the speaker. Recognizing the speaker can simplify the task of translating speech in systems that have been trained on a specific user's voice or it can be used to authenticate or verify the identity of a speaker as part of a security process.
  • voice recognition may be carried out according to any of the methods known in the art.
  • a voice recognition method may be based on hidden Markov models using cepstral coefficients.
  • the employed hidden Markov model may further involve context dependency for phonemes, cepstral normalization to normalize for different speakers and/or recording conditions, vocal tract length normalization (VTLN) for male/female normalization, and/or maximum likelihood linear regression (MLLR) for more general speaker adaptation.
  • VTLN vocal tract length normalization
  • MLLR maximum likelihood linear regression
  • a voice recognition system based on hidden Markov models may further be adapted using discriminative training techniques, such as maximum mutual information (MMI), minimum classification error (MCE) and minimum phone error (MPE).
  • MMI maximum mutual information
  • MCE minimum classification error
  • MPE minimum phone error
  • the voice recognition method may be based on dynamic time warping (DTW).
  • DTW dynamic time warping
  • Other methods, which may be used for detecting a voice signal in the microphone signal using voice recognition include, but are not limited to, e.g., power spectral analysis (FFT), linear predictive analysis (LPC), perceptual linear prediction (PLP), mel scale cepstral analysis (MEL), relative spectra filtering (RASTA) may be used.
  • FFT power spectral analysis
  • LPC linear predictive analysis
  • PPP perceptual linear prediction
  • MEL mel scale cepstral analysis
  • RASTA relative spectra filtering
  • Detecting a voice signal may further comprise detecting voice/speech activity of at least two different human speakers using voice recognition based on speaker recognition methods.
  • Voice recognition may be used by the voice command device to authorize operation of the voice command device.
  • the voice recognition adapts as automatic speech recognition (ASR), computer speech recognition or speech to text (STT).
  • ASR automatic speech recognition
  • STT speech to text
  • a large number of additional units known for voice command devices such as Amazon's Echo may be part of the system of the embodiments.
  • Additional processor units, volatile and non-volatile memory units, storage units, FFT/IFFT units, matrixing units, amplifiers, A/D and D/A converters and the like may be implemented.
  • the user may wake the AMD by verbal communication.
  • the user interface may be incorporated into a sensor for recognizing a voice.
  • voice command e.g., voice command “Alexa” is used for waking up Amazon Echo devices
  • the AMD receives a wake signal and is triggered to prompt the user predefined questions (e.g., “what can I do for you?”).
  • the voice command system may thus constantly monitor the acoustic space for speech signals.
  • each voice command device may analyze the detected speech signal or transmit the speech signal.
  • the user can directly request the AMD to perform the functions (e.g., “hey pump, please start therapy delivery,” “pump, change the time of therapy deliver,” etc.).
  • the user can set the wake-up command. For example, when the wake-up command is set as “hey, pump,” the user can change to the specific name of the pump.
  • the pump may be configured to recognize only a specific user. Other users are prohibited from waking-up and/or controlling the AMD.
  • voice recognition requires “training” (e.g., “enrollment”) where an individual speaker reads text or isolated vocabulary into the voice recognition system of the AMD.
  • the voice recognition system analyzes the user's specific voice and uses it to fine-tune the recognition of the user's voice, resulting in increased accuracy.
  • the communication module 602 may include one or more wireless transceivers, one or more antennas and in or more plurality of electronic systems (e.g., front end modules, antenna switch modules, digital signal processors, power amplifier modules, etc.) that support communication over one or more communication links and/or networks.
  • each transceiver may be configured to receive or transmit different types of signals based on different wireless standards via the antenna (e.g., an antenna chip).
  • the transceiver may support communication using a low power wide area network (LPWAN) communication standard.
  • LPWAN low power wide area network
  • the transceiver may support communication with wide area networks (WAN) such as a cellular network transceiver that enables 3G, 4G, 4G-LTE, or 5G.
  • WAN wide area networks
  • the transceiver may support communication via a Narrowband Long-Term Evolution (NB-LTE), a Narrowband Internet-of-Things (NB-IoT), or a Long-Term Evolution Machine Type Communication (LTE-MTC) communication connection with the wireless wide area network.
  • NB-LTE Narrowband Long-Term Evolution
  • NB-IoT Narrowband Internet-of-Things
  • LTE-MTC Long-Term Evolution Machine Type Communication
  • the transceiver may support Wi-Fi® communication.
  • one or more transceivers may support data communication via Blue tooth or Blue Tooth Low Energy (BLE).
  • BLE Blue Tooth Low Energy
  • the transceiver may be capable of down-converting and up-converting a baseband or data signal from and to a wireless carrier signal.
  • the communication module may wirelessly exchange data between other components of the AMD 600 (e.g., an analyte sensor such as a glucose level sensor or insulin level sensor), a mobile device (e.g., smart phone, a laptop, a tablet, and the like), a Wi-Fi network, WLAN, a wireless router, a cellular tower, a Bluetooth device, and the like.
  • the antenna may be capable of sending and receiving various types of wireless signals including, but not limited to, Bluetooth, LTE, or 3G.
  • the communication module 602 may support direct communication between the AMD and a server or a cloud network.
  • the AMD 600 may communicate with an intermediary device (e.g., a smart phone or other mobile devices, a personal computer, a notebook, a tablet, and the like).
  • the AMD 600 may include an eSIM card that stores information that may be used to identify and authenticate a mobile subscriber.
  • the eSIM card may enable the AMD 600 to function as an IoT device that can communicate over a network that supports communication with IoT devices.
  • the AMD 600 may be configured to transmit data using a narrowband communication protocol such as 2G or EDGE. Using the cellular connection the AMD 600 may be paired with the mobile device at inception and permit real-time data access to the AMD 600 by a healthcare provider.
  • the AMD 600 may include a geolocation receiver or transceiver, such as a global positioning system (GPS) receiver.
  • the communication module 602 may include a Near Field Communication (NFC) sub-system that enables contactless data exchange between the AMD 600 and an electronic device located in the vicinity of the AMD 600 .
  • NFC Near Field Communication
  • a glucose sensor interface in the communication module 602 may be configured to receive glucose level signals from an analyte sensor, a glucose level sensor, and/or insulin level sensor, hereinafter referred to as “subject sensor” 620 .
  • the subject sensor 620 can be a wearable continuous glucose monitor (CGM) that is operatively connected to the subject 622 .
  • CGM wearable continuous glucose monitor
  • the subject sensor 620 may be attached to a site on subject's body using adhesive patch holds and may include a cannula that penetrates the subject's skin allowing the sensor to take glucose readings in interstitial fluid and generate glucose level signals that indicate the level of glucose in subject's blood.
  • the glucose sensor interface may receive the glucose level signals from the subject sensor 620 via a wired or wireless link.
  • each of the AMDs described herein may include one or more of the embodiments described with respect to the other AMDs unless specifically stated otherwise.
  • the AMD (or GLCS) 600 may continuously, periodically (e.g., every 5 minutes, every 10 minutes, etc.), or intermittently receive information associated with one or more parameters (e.g., parameter values) that are correlated with a health condition of the subject 622 (e.g., glucose level, glucose level trend, insulin level, insulin level trend, heart rate, body movement indicia, etc.).
  • This information may be encoded to a signal provided to AMD 600 by an analyte sensor (e.g. a glucose sensor), which can be the subject sensor 620 that is connected to the AMD 600 via a wired or wireless link (e.g., Bluetooth).
  • an analyte sensor e.g. a glucose sensor
  • a wired or wireless link e.g., Bluetooth
  • AMD 600 may receive glucose level signals that carry encoded glucose level data usable to determine a glucose level of the subject 622 , from a continuous glucose monitor (CGM).
  • CGM continuous glucose monitor
  • a CGM may be a wearable biomedical sensor that measures a glucose level in an interstitial fluid of the subject.
  • a glucose level signal may comprise an electronic signal indicative of a measured glucose level of the subject 622 .
  • the measured glucose level associated with a glucose level signal may be correlated with a physiological glucose level of the subject.
  • the physiological glucose level of the subject can be a concentration of glucose in subject's blood or an interstitial fluid in part of the subject's body (e.g., expressed in milligram per deciliter (mg/dl)).
  • the glucose level of the subject may comprise a measured glucose level of the subject.
  • the measured glucose level of the subject may be associated with a measured concentration of glucose in an interstitial fluid of a subject's body.
  • the concentration of glucose in the interstitial fluid of the subject's body may be correlated to a glucose level of the subject.
  • Measured glucose level may be referred to herein as “glucose level of the subject” or “glucose level”.
  • the AMD (or GLCS) 600 may continuously, periodically or intermittently receive glucose level signals from the subject sensor 620 (e.g. a glucose level sensor) via a glucose sensor interface (e.g., via a wired or a wireless data connection).
  • the glucose sensor interface may be included in the communication module 602 .
  • the glucose sensor interface may be separate from the communication module 602 .
  • the glucose level signal sent by the subject sensor 620 may be received by the communication system 602 and transmitted to control and computing module 610 where the signal may be analyzed to determine whether medicament should be delivered to the subject 622 .
  • a second communication system may be included in the AMD (or GLCS) 600 to communicate with the subject sensor 620 .
  • control and computing module 610 may determine the dosage and type of medicament to administer based on the information received from the subject sensor 620 , generate a dose control signal, and send it to therapy delivery module 606 to initiate the medicament delivery to the subject.
  • the dose control signal may be received by the pump controller that controls the operation of the infusion pump.
  • control and computing module 610 may perform one or more procedures using the processor 614 (or a plurality of processors) that execute the instructions stored in the main memory 616 . These procedures include, but are not limited to, determining the need for delivering medicament, determining the type of medicament and the required dose, determining the rate of delivery during a therapy session, providing information (e.g., device status, next delivery time, level of certain analytes in the subject's blood and the like) via the user interface module 608 , processing the data received from the subject 620 , managing access to control parameters (e.g., by controlling one or more therapy change controls that may be provided by the user interface module 608 ).
  • these procedures include, but are not limited to, determining the need for delivering medicament, determining the type of medicament and the required dose, determining the rate of delivery during a therapy session, providing information (e.g., device status, next delivery time, level of certain analytes in the subject's blood and the like) via the user interface module 608 , processing the data
  • an amplitude of the glucose level signal may be proportional to or correlated to the glucose level of the subject.
  • a glucose level signal may carry glucose level data (e.g., measured glucose level values or information usable to determine glucose level values).
  • the glucose level signal, generated by the glucose sensor e.g., subject sensor 620
  • the glucose level signal may comprise encoded glucose level data.
  • the glucose level signal may comprise glucose level data encoded onto a carrier signal, for example, using amplitude modulation, frequency modulation, and/or phase modulation.
  • the glucose level signal can be an analog signal encoded with data associated with the glucose level data.
  • the glucose level signal can be transmitted via a wireless link (e.g., a Bluetooth link, a Wi-Fi link, a cellular data link, and/or other wireless network infrastructure) and received by a wireless receiver included in a glucose sensor interface.
  • the glucose sensor interface can be included in the communication module 602 .
  • the glucose sensor interface can a separate module or system in the AMD 600 .
  • the glucose sensor interface may direct the glucose level signal to the control and computing module 610 .
  • the control and computing module 610 may decode the glucose level data from the glucose level signal.
  • the glucose level data may be decoded by the glucose sensor interface.
  • the glucose level signal sent by the subject sensor 620 may be received by the communication module 602 and transmitted to the control and computing module 610 .
  • the control and computing module 610 may determine a dose and a delivery time of a medicament (e.g., insulin or glucagon) based at least in part on the glucose levels of the subject 622 decoded from the received glucose level signals. Subsequently, the control and computing module 610 may generate a dose control signal and transmit the dose control signal to the therapy delivery module 606 of the AMD 600 , to cause the delivery of the determined dose of medicament at the determined delivery time to the subject 622 . The control and computing module 610 may generate the dose control signal using a control algorithm. In some cases, the control algorithm may comprise a model-predictive control (MPC) algorithm and/or a basal control algorithm.
  • MPC model-predictive control
  • the signal (e.g., the glucose level signal) sent by the subject sensor 620 may be received by the communication module 602 (e.g., a sensor interface in the communication module 602 ) and transmitted to a signal processing module 604 that converts the signal to a machine-readable signal (e.g., a digital signal).
  • a second communication module separate from the communication module 602 may be included in the AMD 600 to communicate with the subject sensor 620 .
  • the signal processed by the signal processor module 604 may be transmitted to the control and computing module 610 where the signal may be analyzed to determine whether medicament should be delivered to the subject 622 .
  • control and computing module 610 may determine the dosage and type of medicament to administer based on the information received from the subject sensor 620 , generate a dose control signal and send a dose signal to the therapy delivery module 606 (e.g., directly or via the signal processing module 604 ) to initiate the medicament delivery to the subject (e.g., using an infusion pump of the therapy delivery module 606 ).
  • one or more procedures within the control and computing module 610 may be executed by the processor 614 (or a plurality of processors) based on instructions provided by one or more software applications installed in one of the memories (e.g., the main memory 616 ) of control and computing module 610 .
  • These procedures include, but are not limited to, determining the need for delivering medicament, determining the type of medicament and the required dose, determining the rate of delivery during a therapy session, providing information (e.g., device status, infusion set usage, infusion set status, subject sensor usage, transmitter status, transmitter usage, subject sensor 620 status, next delivery time, level of certain analytes in the subject's blood and the like) via the user interface module 608 , processing the information received from a subject sensor 620 via the user interface module 608 , managing access to control parameters (e.g., by controlling one or more therapy change controls that may be provided by the user interface module 608 , and the like).
  • information e.g., device status, infusion set usage, infusion set status, subject sensor usage, transmitter status, transmitter usage, subject sensor 620 status, next delivery time, level of certain analytes in the subject's blood and the like
  • processing the information received from a subject sensor 620 via the user interface module 608 e.g., managing access to control parameters
  • a first software application may control the AMD 600 and may be installed on the main memory 616 while a second software application (e.g., different version) may be stored in the storage 618 .
  • the first and second software applications may be both installed in the main memory 616 but in different locations or segments. In some such examples, if needed, the control of the device can be switched from the first software application to the second software application.
  • the AMD 600 may deliver multiple types of therapies that are selectable by a user or the control and computing module 610 .
  • the AMD 600 may deliver the therapy of infusing insulin into a user and may also deliver the therapy of infusing glucagon into a user.
  • the user interface may include an option for the user to select an infusion of insulin, glucagon, or both insulin and glucagon.
  • other hormones, liquids, or therapies may be delivered.
  • the software application executed by the control and computing module 610 may determine the type of hormone that needs to be delivered, at least partly based on the information received from the subject sensor 620 .
  • the AMD 600 may allow the user or the subject 622 to announce to AMD 600 that the infusion set has been replaced.
  • the user interface module 608 may generate a user interface on a touch screen display that allows the user or the subject 622 to enter a time and a date at which the infusion set has been replaced.
  • the AMD 600 may provide the user or the subject 622 a user interface (e.g., via a touch screen display) that allows delivery of glucose therapy to the subject 622 upon request.
  • a user interface e.g., via a touch screen display
  • the user interface module 608 may generate a medicament bolus or medicament burst user interface on a touch screen display that allows the user to enter a dose of a medicament for immediate delivery.
  • a regulatory medicament bolus can be a meal bolus requested and delivered in anticipation of food intake.
  • a counter-regulatory medicament bolus can be delivered in anticipation of physical activity (e.g., swimming or running), or similar to how a meal bolus can be delivered in anticipation of food intake.
  • a medicament bolus may be requested and delivered to maintain the glucose level of the subject 622 within a set range during a period of time when the subject 622 does not receive therapy from the AMDs 600 .
  • the subject 622 may request a medicament bolus via the medicament burst user interface when he or she expects to be disconnected from the AMDs 600 for a period.
  • FIG. 7 illustrates various methods and links or communication paths that an AMD (or GLCS) 702 may use to communicate (e.g., by establishing a connection) with a host computing system 704 (e.g., a remote computing environment), for example, to obtain an application update, send and/or receive therapy reports, facilitate ordering of infusion sets, analyte sensors, transmitters, and/or a new AMD, receive passcodes, send and receive electronic requests, receive values of control parameters, send or receive aggregate reports, and the like.
  • a host computing system 704 e.g., a remote computing environment
  • the host computing system 704 may be a server 706 or a computing system within a cloud based computing systems 708 , or other networked computing environments, that provide networking computing services (e.g., network storage, application hosting, and/or network processing services).
  • the host computing system 704 may be part of a data center (e.g., the data center of a healthcare provider).
  • the host computing system 704 may be a computing system of a healthcare provider, a healthcare professional, a manufacturer, or a payer (e.g., an insurance company). In some examples, the host computing system 704 may be part of a patient data network or be connected to a patient data network. The patient data network may comprise a local storage of patient data or a cloud storage. In some cases, the host computing system 704 may be in communication with a data center of a healthcare provider, a health institute, or a payer.
  • the AMD (or GLCS) 702 may establish a connection (e.g., using the communication module 602 ) with the host computing system 704 through an intermediary device 710 (e.g., a smart phone or other mobile devices, a personal computer a notebook or the like).
  • the server 706 can be an electronic device can be a desktop computer, a mobile phone, a notebook, or any electronic device capable of establishing a data connection with the AMD 702 and receiving data from the AMD 702 .
  • the AMD 702 may receive an application update from an intermediary device 710 of a user (e.g., a clinical computer, a subject's home computer, a smartphone, etc.) that has obtained a copy of the application update from the host computing system directly or via internet 714 .
  • the AMD 702 may communicate with the host computing system 704 through a local area network (LAN) and/or through a Wi-Fi connection.
  • the AMD 702 may establish a communication connection to the host computing system 704 via a wide area network (WAN) 716 .
  • WAN wide area network
  • the communication between the AMD 702 and the host computing system 704 may be encrypted.
  • the AMD 702 may establish a direct end-to-end communication connection over a wide area network (WAN) 716 (e.g., a cellular network) with the host computing system 704 .
  • a direct-end-to-end communication connection may be a connection that does not involve a local device, a device that is accessible by the user or the subject (besides the AMD 702 ), a Wi-Fi network, a short range wireless link (e.g., Bluetooth), or the like.
  • the direct end-to-end communication may pass through one or more wireless systems (e.g., receivers, transmitters or antenna) of a WAN.
  • the host computing system 704 may establish the end-to-end connection by receiving a public key from the AMD 702 .
  • the public key and a private key stored in the host computing system 704 can be used to permit the host computing system 704 to decrypt data communications transmitted by the AMD 702 .
  • the host computing system 704 may send a public key to the AMD 702 that allows the AMD 702 to encrypt data (e.g., therapy data). Up one receiving the encrypted data from the AMD 702 the host computing system 704 may use a private key stored in its memory, to decrypt the data.
  • the host computing system 704 may establish a direct end-to-end data connection with the AMD 702 based on receiving a device identifier associated with the AMD 702 .
  • the device identifier may be a unique identifier specific to the AMD 702 .
  • establishing the direct end-to-end data connection may include determining that the AMD 702 is permitted to communicate with the host computing system 704 based at least in part on the device identifier.
  • the device identifier may be initially provided to the networked-computing environment prior to provisioning of the AMD 702 to the subject. For example, the device identifier may be initially provided to the networked-computing environment as part of a manufacturing process for manufacturing the AMD 702 .
  • the device identifier may include or may be based on one or more of an Internet Protocol (IP) address, a Media Access Control (MAC) address, a serial number, or a subject identifier of a subject that receives therapy from the AMD 702 .
  • IP Internet Protocol
  • MAC Media Access Control
  • the subject 622 or a user may establish or initiate establishing the direct end-to-end data connection with the host computing system 704 .
  • the direct end-to-end data connection may be initiated or established without any action by the subject or the user.
  • the direct end-to-end data connection may be established automatically at particular times and/or when the AMD 702 is in a particular location. In some such cases, this automatic connection may occur using information supplied to the AMD 702 at a time of manufacture, shipment, sale, or prescription to the subject.
  • a subject or other user may configure the AMD 702 to automatically connect to the host computing system 704 at particular times and/or locations.
  • the local area networks 712 or wide area networks 716 include, or may communicate with, the Internet 714 .
  • the AMD 702 may be configured to communicate via the wide area network 716 during manufacture or prior to being provisioned to the subject.
  • a manufacturer can register the AMD 702 with a wireless wide-area network provider (e.g., T-Mobile, Verizon, etc.) and provide an International Mobile Equipment Identity (IMEI) number or serial number for the AMD 702 to the network provider.
  • IMEI International Mobile Equipment Identity
  • fees can be negotiated between the manufacturer and the network provider or between the subject's health insurance and the network provider.
  • fees may be paid by the manufacturer or health insurance provider, or other entity, without subject involvement.
  • the subject's AMD 702 may be configured to communicate via the network of the network provider without any action by the subject or the user.
  • the subject may be responsible for obtaining wireless service to connect the AMD 702 to a wide area network 716 (e.g., a cellular network).
  • the AMD 702 may be pre-registered or authenticated with a computing network of the cloud services provider as part of the manufacturing process or before AMD 702 is provided to the subject. This enables the AMD 702 to communicate over the wide area network 716 with the computing system of the cloud services provider from day one without any or with minimal configuration by the subject.
  • a user such as a healthcare provider may register or associate the AMD 702 with the subject at the computing network of the cloud services provider.
  • the AMD 702 may use a whitelist, or approved list, that identifies via a unique identifier (e.g., via an IP address, a MAC address, or a URL) one or more permitted cloud servers or computing systems of the cloud based computing system 708 that the AMD 702 is permitted to access.
  • a unique identifier e.g., via an IP address, a MAC address, or a URL
  • the risk of malicious actors accessing the AMD 702 is reduced.
  • the whitelist may be stored in a memory of AMD 702 and/or in a memory of a trusted computing device that is accessible by the AMD 702 .
  • the trusted computing device can include any computing device that a manufacturer of the AMD has identified as trusted.
  • the trusted computing device can include any computing device that a subject or user that helps caste for the subject (e.g., parent, guardian, healthcare provider) has identified as a trusted computing device that is designated to store the whitelist.
  • the whitelist may be configured during manufacture of the AMD 702 .
  • the whitelist may be configured with connection information to establish communication with one or more computing systems of a networked-computing environment.
  • the AMD 702 may be configured to execute the specific computer-executable instructions to at least obtain an address of a computing system from the whitelist and to establish a direct end-to-end data connection to the computing (e.g., a computing system in the networked-computing environment), via a wireless wide area network using the address.
  • the AMD 702 may be configured to execute the specific computer-executable instructions to at least receive a public key from the computing system of the networked-computing environment.
  • the AMD 702 may include a blacklist, or restricted list, that identifies systems the AMD 702 is not permitted to access.
  • the blacklist may be updated as more restricted or unsafe websites, network accessible systems, or computing systems are identified.
  • the whitelist may be updated over time if approved systems are added or removed.
  • the cloud based computing system 708 service may have a whitelist, or approved list, that uses unique identifiers to specify AMD 702 and/or other computing systems (e.g., remote display systems) that are permitted to communicate with the cloud based computing system 708 .
  • the cloud based computing system 708 may have a blacklist or restricted list that identifies AMDs, or other computing devices, that are not permitted to access the cloud computing services.
  • An AMD may be added to the restricted list if it is decommissioned, damaged, or is no longer in possession of the subject. It may be desirable to remove an AMD's access to the cloud computing service to help protect private or personal data of a subject.
  • the whitelist may include any information that may facilitate access to the systems identified on the whitelist.
  • the whitelist may include access information (e.g., usernames, passwords, access codes, account identifiers, port identifiers, a shared secret, public keys, etc.).
  • access information e.g., usernames, passwords, access codes, account identifiers, port identifiers, a shared secret, public keys, etc.
  • the whitelist may include different information depending on whether the whitelist is publicly accessible, accessible by only the AMD, accessible by authorized users or devices, etc. For example, a publicly accessible whitelist or a whitelist accessible by more than one authorized system or user may not include passwords or access codes.
  • a computer application is updated after it is released.
  • the application is updated to patch bugs or vulnerabilities.
  • the application is updated or replaced with a new version to introduce new features or improve existing features.
  • an application is shutdown or is not executing while the application is updated.
  • it is inconsequential that a video game, word processing, or edutainment application is not executing while it is updated.
  • an application on an ambulatory medical device can be inconvenient, harmful, or, in some cases, life-threatening to cause an application on an ambulatory medical device to cease executing while it is updated or replaced by a new version of the application.
  • a subject or subject that is receiving therapy from the ambulatory medical device enters a state where therapy is desired or needed while an application or control software of the ambulatory medical device is being updated or replaced, harm may occur to the subject.
  • the ambulatory medical device is an insulin pump, such as those that may be used by a type-1 diabetic.
  • the user may not receive a necessary insulin bolus from the ambulatory medical device.
  • an ambulatory medical device includes a computer-implemented method of updating an application executing on the ambulatory medical device without interrupting, or while causing minimal interruption, to therapy provided by the ambulatory medical device to a subject or subject.
  • the method may generally be performed by a hardware processor, (e.g., a controller, and the like), included in an ambulatory medical device and based on a set of instructions that may be stored, for example, in a non-transitory memory of the AMD.
  • the application update may be a new version of the application, a replacement or substitute application, or an application patch.
  • the application may be an older version of the application that has been used by instances of the ambulatory medical device for more than a threshold period of time and has experienced less than a threshold number of faults.
  • the application update may be stored in one or more host computing systems.
  • the application update may be pushed to the host computing systems by a company that manages or manufactured the ambulatory medical device or other software company that is authorized by the manufacturer or licensee of the device.
  • FIG. 8 is a flow diagram showing an example of a computer-implemented method that may be used by the AMD in order to detect and download an application update from a host computing system or other computer readable media in which a copy of the application update is stored.
  • an ambulatory medical device such as a medicament delivery device or a medicament pump may receive an indication 802 that an update is available for an application, such as control software or other software that controls or facilitates the operation of the ambulatory medical device.
  • the software update may include a binary executable file for various processors of the ambulatory medical device.
  • the indication may be a determination made by a software or hardware module included in an ambulatory medical device of AMD.
  • the AMD may access a particular host computing system (e.g., using its communication module) to determine whether an update is available, based on set of update trigger conditions stored in a memory of AMD.
  • the set of update trigger conditions may be defined/changed by a user and/or received by AMD from a host computing system.
  • a trigger condition may push the AMD to periodically search for an update at time intervals set by the user or received from a host computing system.
  • the ambulatory medical device may access a particular host computing system to determine whether an update is available to an application installed on the AMD.
  • the software to be updated on the AMD may be currently executing on the ambulatory medical device or may be executed in future.
  • the indication may a query received from the host computing system that may access the AMD to read and compare the software versions and the hardware configuration (and warranty) to determine the eligibility of the ambulatory medical device for a software upgrade.
  • the serial number, the model number, and/or the software version may be used to determine software upgrade eligibility.
  • the eligibility may be determined based on the geoposition of the device and/or whether the device is connected to a local area network (such as for example, a Wi-Fi network) or a wide area network (such as, for example, a cellular network).
  • the ambulatory medical device may have an antenna that provides the device with GPS, text or picture messaging, telephone calling, and data transfer capabilities.
  • Software update may be provided on a limited release with test groups of varying sizes, e.g., 1-100 or 1-1000 or 1-10000. There may be a phase rollout of the software updates.
  • the AMD may respond to an upgrade eligibility request with a version of the first software or a model identification information of the ambulatory medical device or a manufacturing date of the ambulatory medical device.
  • the ambulatory medical device may establish a connection 804 to a host computing system that hosts the update to the application.
  • Such connection may be established via one or more links or methods discussed above with reference to FIG. 7 .
  • the ambulatory medical device may download the application update or application update from the host computing system over the connection 806 .
  • the ambulatory medical device may download an image of the application update from the host computing system. While the application update is being downloaded, an existing version of the application on the ambulatory medical device may continue to execute. Thus, there is little or no interruption to therapy provided by the ambulatory medical device while the application update is being obtained by the ambulatory medical device.
  • the ambulatory medical device may perform one or more operations to confirm that the application update was successfully downloaded from the application host system and that the download was not corrupted 808 .
  • the ambulatory medical device may calculate a hash or checksum value from the downloaded application update. This hash or checksum value may be compared with one received from the application host system. If the calculated hash or checksum value matches the received hash or checksum value, then it may be determined that the download is both complete and not corrupt. Further, the ambulatory medical device may use the checksum, a tag, a payload size, or any other method to confirm that the download of the application update is complete and not corrupt.
  • the AMD discards the corrupt copy and downloads another copy of the update. If it is determined that the download is complete and not corrupt, the AMD may proceed to the installation step 810 wherein the application update may be installed on the AMD without interrupting the ongoing or upcoming therapy sessions.
  • FIG. 9 - FIG. 11 are flow diagrams illustrating examples of computer-implemented methods that may be used by the AMD to install a downloaded application update without disrupting the therapy provided to a subject.
  • the control and computing module (CCM) of the AMD 600 may determine the amount of time required to install the application update 904 and wait for a trigger signal 906 to initiate installation process.
  • the CCM 610 may notify to the user 908 through a user interface (e.g., a touchscreen display), that an update is ready for installation. The notification may include the installation time and information about the update. In such examples, if a trigger is not received, CCM 610 may send one or more notifications to the user indicating that a new update is ready for installation.
  • the trigger may be the confirmation that the application was successfully downloaded.
  • the trigger may be a user command received based on an interaction by a user or subject with a user interface that is part of or that communicates with the ambulatory medical device.
  • the installation time may be determined by the CCM based on data or metadata provided with the downloaded application update.
  • the application update may include a file (e.g., a text file or configuration file) that includes the install time.
  • the installation time may be determined by the manufacturer of the ambulatory medical device or the publisher of the application update. For example, the developer of the software update may average the install time across several test devices to determine the install time metadata that is provided with the software update.
  • General purpose computers have a wide variety of configurations and the performance of a general purpose computer may vary depending on the applications executing at a particular time. Thus, the determination of install time for an application based on the measurement of install time on a test device is typically unreliable.
  • an install time determined during testing by a manufacturer may in many cases be a reliable determination of install time on an ambulatory medical device of a subject.
  • the install time of an application update may be determined or estimated based on a size of the application update.
  • the provided or estimated install time may include a buffer. In other words, an additional amount of time may be added to the install time to account for variances in operating condition of the ambulatory medical device or inaccuracies in the estimated install time.
  • the CCM may check for any ongoing therapy session 910 . If the no therapy is currently being administered, the CCM determines the next therapy time 914 (or the time left until the next therapy session). If therapy is currently being administered the installation will be delayed 912 until the therapy session is compete. Once the current therapy session is complete, the CCM may determine the time remaining until next therapy session 914 (e.g., during which medicament, such as insulin is delivered to a subject).
  • the determination of the next time that therapy is to be delivered may be an estimate based on historical delivery of therapy, a present condition of the subject (e.g., when a glucose level is of a subject is at the center of a desired range, the next therapy delivery time may be estimated to be further off than when the glucose level is at the edge of the desired range), and/or an indication provided by a user or subject (e.g., an indication that the user is planning to have a meal, to exercise, or to go to sleep).
  • the determination of the next time that therapy is to be delivered may be based on a scheduled delivery of therapy (e.g., every 5 minutes or every hour).
  • the estimated install time may be compared 916 to the determined or estimated next therapy delivery time to determine whether the installation of the application update can be completed before the next therapy delivery to the subject. If it is determined that the time left until the next therapy session is sufficiently longer than the determined time for completing the installation, installation of the application updated may be initiated 918 .
  • the determined time to the next therapy session has to be longer than the determined installation time by a threshold value. Such threshold value may be different for different application updates and/or the type of next therapy session.
  • the installation of the application may be delayed, regardless of receipt of the trigger.
  • the CCM may wait for the next therapy to be completed and then determine a new therapy time 914 . This process may be repeated until CCM determines that the update can be installed without interrupting an expected or scheduled therapy by the ambulatory medical device.
  • a new determination may be made before completion of the next therapy, to determine whether installation may be completed prior to a subsequent therapy time after the next therapy time.
  • a time when the application can be installed without interrupting therapy may not be identified.
  • a user e.g., a clinician or other medical provider, or a subject
  • the user may be provided with an alert that an application update is available and/or that the application update cannot be installed without interrupting therapy.
  • the user may be provide with an option as to whether to permit the update and/or when to install the application update.
  • the option may include presenting the user with the estimated install time enabling the user to schedule the application update at a time when interruptions to therapy may be minimal or when an alternative source of therapy (e.g., injection therapy) can be utilized.
  • an alternative source of therapy e.g., injection therapy
  • the AMD's control and computing module may notify the user and wait for a trigger signal before determining the installation time. Once the trigger has been received, the CCM initiates the installation process of the downloaded copy of the application update without interrupting therapy provided by the ambulatory medical device to the subject.
  • the application update may be installed in a different memory location than the memory location where the original application is installed and executed.
  • FIG. 10 is flow diagram illustrating an example of a computer-implemented method that may be used by the AMD in order to install a second application that is an update to a first application executing on the ambulatory medical device, without disrupting the therapy provided to a subject.
  • the CCM may initiate the installation process of the second application 1004 without interrupting the execution of the first application.
  • the CCM may confirm 1006 the successful installation of the second application and wait for a trigger signal 1010 to initiate the execution of the second application in place of the first application.
  • the installation of the second application may be confirmed by sending a notification the user 1008 via a user interface of the AMD.
  • the CCM may determine the amount of time required for switching the control of AMD to from the first application to the second application.
  • the notification may include information about the update and the time required for switching between the applications.
  • the trigger may be a user command received based on an interaction by a user or subject with a user interface that is part of or that communicates with the ambulatory medical device. In such examples, if a trigger is not received the AMD may send one or more notifications to the user indicating that a new update is ready for installation. If a trigger is received, the CCM may check for any ongoing therapy session 1012 .
  • the CCM determines the next therapy time 1016 (or the time left until the next therapy session). If therapy is currently being administered the installation will be delayed 1014 until the therapy session is compete. Once the current therapy session is complete, the CCM may determine the time remaining until next therapy session 1016 . The estimated next therapy delivery time may be compared to a set threshold time to determine whether the switching from the first application to the second application can be performed without interfering with the next therapy session. If it is determined that the time left until the next therapy session is longer than the set threshold time 1018 , the execution of the second application will be initiated and the execution of the first application will be halted 1020 . In some examples, the set threshold time may be determined by the CCM at least partly based on the time required to execute of the second application and halt the first application. In some examples, the set threshold time may be received from a host computing system.
  • the performance of an application update may be tested before switching control of the AMD to the application update.
  • FIG. 11 illustrate an example method that may be used by such embodiment.
  • the AMD verifies that an uncorrupted copy of the update for a first application is successfully downloaded 1102 (e.g., using the procedure described above with reference to FIG. 8 ).
  • the AMD may install 1104 and execute 1106 the downloaded copy of the second application without interrupting the execution of the first application and therefore the therapy that might be provided by the ambulatory medical device to the subject.
  • the second application update may be installed to a separate portion (e.g., a separate execution space or separate memory) from the portion where the first application is installed and is being executed.
  • the Control and computing module (CCM) of the AMD may determine that a minimum set of operating conditions 1108 are satisfied by the second application 1110 , wherein the minimum set of operating conditions relate to maintaining therapy provided by the ambulatory medical device to the subject. If it is determined that the minimum set of operating conditions are not satisfied by the second application, the AMD may wait for an indication that a third application is available 1112 and repeat the procedure described above to evaluate the performance of the third application. If it is determined that the minimum set of operating conditions are satisfied by the second application, the AMD may check for an ongoing therapy session 1114 . If it is determined that currently no therapy is provided to a subject, CCM may switch the control of the ambulatory medical device from the first application to the second application 1118 . If currently therapy is provided to a subject, the CCM may wait until the therapy session is competed 1116 and then switch the control of the AMD from the first application to the second application.
  • CCM Control and computing module
  • the ambulatory medical device may be updated (or downgraded) to add (or remove) features from the ambulatory medical device.
  • the ambulatory medical device may initially provide only insulin therapy.
  • the ambulatory medical device may be upgraded to include bi-hormonal control (e.g., to provide both insulin therapy and counter-regulatory agent (e.g., Glucagon) therapy).
  • the upgrade may be based on newly available features and/or based on a decision by a user to purchase or otherwise obtain additional features.
  • a user may opt to downgrade therapy from bi-hormonal to insulin-only therapy.
  • the upgrade or downgrade may be made based on the availability of medicament.
  • a first update can be a first application version comprising a first feature set (e.g., providing insulin therapy) and a second update can be a second application version comprising a second feature set (e.g., provide both insulin therapy and Glucagon therapy).
  • the first feature set may comprise a subset of the second feature set.
  • the first feature set may comprise a partially overlapping set of features with the second feature set.
  • a computer-implemented method that may be used by the AMD in order to detect, download and install an update to an application executing on the ambulatory medical device wherein the application comprises one of a first application version comprising a first feature set or a second application version comprising a second feature set.
  • the first feature set may comprise partially overlapping set of features with the second feature set.
  • the first feature set may comprise partially overlapping set of features with the second feature set.
  • the AMD may receive an indication of availability of the application update, download the application update and verify that an uncorrupted image of the application update is successfully downloaded (e.g., using the procedure described above with reference to FIG. 8 ).
  • control and computing module (CCM) of the AMD may initiate the installation process of the application update image without interrupting the execution of the application.
  • the indication received by the AMD may include information about application update being an update to the first application version or to the second application version.
  • the CCM may determine the version of the application update and download the application update image based on the determined version
  • any downloaded application update may be installed to a separate portion (e.g., a separate execution space or separate memory) from a currently executing version of the application.
  • the active version of the application can be switched. For example, control of the ambulatory medical device can be provided to the updated application, the previously executing application can be ceased or halted. The old application can then be removed, or kept as backup. Determining when to switch which version of the application is active may follow a similar process as previously described for identifying a next therapy delivery time and selecting a time to switch active versions of the application when there will not be an interruption to the therapy provided by the ambulatory medical device.
  • the ambulatory medical device may be configured to store multiple instances of an application (e.g., ambulatory medical device control software).
  • the ambulatory medical device may have a current, or first, version of the application that it is installed in a first memory location (e.g., in the main memory 616 ) and is executing to, for example, control therapy provided by a subject.
  • the ambulatory medical device may include an updated, or second version of the application installed in a second memory location (e.g., in the main memory 616 ).
  • the update of the second version may have been downloaded and installed (e.g., in a prior to detection of the fault).
  • the ambulatory medical device may initiate the execution of the second version of the application and then switch control of the AMD to the second version of the application to maintain therapy to the subject.
  • the second version of the application installed on the AMD may be a version older than the first version, or version that may not have track a record of stability and reliability.
  • FIG. 12 is a flow diagram for such examples.
  • the control and computing module (CCM) of the AMD may switch the control of the AMD to the second version of the application 1204 while searching for a third update 1206 .
  • the CCM may establish a connection with a host computing system configured to host a third update and download and install the third update 1208 .
  • the third version of the application may be a new version, a version prior to the first version, an update to the first application that addresses the detected application-fault or an older version that satisfies the conditions to be classified as a “safe version” (e.g., less than a threshold number or rate of faults over a minimum period of time).
  • the second version (installed in the device) may control the AMD while the third version is being downloaded and installed 1208 without interrupting the therapy.
  • the CCM may initiate the installation process of the downloaded copy of the third application and switch control of the ambulatory medical device form the second application to the third application 1210 without interrupting therapy provided by the ambulatory medical device to the subject
  • a “safe version” of the application may have been installed on the ambulatory medical device prior to detection of a fault.
  • the safe version of the application may include a version of the application that has been used by instances of the ambulatory medical device for more than a threshold period of time and has experienced less than a threshold number of faults.
  • the safe version of the application may be a two-year old version of the application that has demonstrably had less than a threshold number of faults occur over the period of two years.
  • This safe version of the application may have less features than the first or second version of the application.
  • the ambulatory medical device may switch control of the device to the safe version of the application to maintain therapy to the subject.
  • the ambulatory medical device may revert to the current version or a safe version installed on the AMD.
  • the AMD may be triggered to establish a connection with the host computing system and search for the second version once a fault is detected during execution of the first version.
  • the ambulatory medical device may revert to the safe version (installed in the device) while downloading and installing the second version without interrupting the therapy.
  • FIG. 13 is a flow diagram illustrating yet another example of a method of responding to a fault detection by the AMD.
  • the control and computing module (CCM) of the AMD may look for a second version of the application 1304 in the main memory or the storage. If it is determined that the second version has been already downloaded, the CCM will determine 1306 whether the second version of the application is installed in a memory location and is ready to be executed. If it is determined that the second version of the application is installed, the control of the AMD will be switched to the second version of the application 1308 .
  • CCM determines that the second version exists in the memory but it is not installed, it will switch the control of the AMD to a safe version that may be already installed 1316 and then initiates the installation 1318 of the second version.
  • the CCM may switch control of the AMD from the safe version of the application to the second version of the application.
  • the CCM may search for a third version of the application 1310 that may be an update to the previously downloaded second version. If a third version is found, the CCM may download and install the third version 1312 and switch the control of the AMD to the third version 1314 .
  • the CCM if it cannot find a second version of the application in a memory or storage location, it will switch the control of the AMD to a safe version of the application 1320 that may be installed in a memory location (e.g., in the main memory or in the storage) and then search for a third version of the application 1310 . If a third version is found, the system may download and install the third version 1312 and switch the control of the device to the third version 1314 .
  • the AMD may transmit an indication of the application-fault to the host computing system of a manufacturer or maintenance service of the ambulatory medical device.
  • the AMD may notify the user when an application-fault occurs through a user interface of the AMD or user interface communicating with the AMD.
  • An ambulatory medical device such as an ambulatory medicament device (e.g., glucose level control system (e.g., an insulin pump or a bi-hormonal pump that includes insulin and a counter-regulatory agent), a pacemaker, or any type of medical device that may be connected to a subject to provide therapy to the subject, can generate a significant amount of data related to therapy provided to a subject (therapy data).
  • This therapy data may be useful for the subject, a healthcare provider, or other users (e.g., parent or guardian) to actively manage the subject's health condition.
  • the therapy data may be useful to determine whether a modification to therapy may be desirable or to confirm that intended therapy is being delivered at the right time.
  • the data may be used to generate an alerts about the health condition of the subject when therapy data indicates that immediate attention is needed with regards to subject′ health condition.
  • Various aspects of accessing the therapy data or other types of data stored in a memory of the AMD needs proper management in order to provide uninterrupted, secure, and easy access to authorized users.
  • the procedures and task performed by an AMD may be associated with certain computer-executable instructions stored and executed by the control and computing module 610 of the AMD 600 .
  • different AMD configurations used for various data transfer management tasks may be configurations of the control and computing module 610 of the AMD 600 .
  • Accessing the data from the ambulatory medical device can be problematic in some cases. For example, accessing the data may require a user to connect the ambulatory medical device to a computer to upload the data. This places a burden on the user to remember to connect the ambulatory medical device. Further, during the period when the device is connected to the computer, the subject may not be receiving therapy from the ambulatory medical device. In some cases, the subject may not be capable of connecting the device to the computer (e.g., when the AMD is not within range of the local device) and may not have someone available to assist the subject. Thus, a direct end-to-end connection to a computing system that (e.g., computing system of a healthcare provider) can safely share data (e.g., therapy data) with authorized users may facilitate data management and access.
  • a computing system e.g., computing system of a healthcare provider
  • data e.g., therapy data
  • FIG. 14 is a block diagram illustrating an example network configuration wherein the AMD 1402 is directly connected to a computing system 1406 in addition to environmental sensors 1404 and medical sensors 1408 .
  • the computing system 1406 may be part of networked computing environment 1412 (e.g., a data center, networked computing system), or cloud network 1410 or cloud computing system of a cloud service provider.
  • the computing system may include one or more non-transitional memories and one or more hardware processors configured to execute the computer-executable instructions stored in one or more non-transitional memories.
  • the procedures performed by the computing system may be associated with the execution of certain computer-executable instructions stored in a memory of the computing system by a hardware processor of the computing system.
  • the direct end-to-end data connection may be supported by one or more transceivers in AMD's communication module 602 .
  • a direct connection may be established between the AMD 1402 and the computing system 1406 over a wide area network (e.g., a cellular network) without using an intermediary system using various wireless standards and technologies (e.g., 4G, 5G and the like).
  • the transceiver may support communication via communication standards, including but not limited to, low power wide area network (LPWAN), Narrowband Long-Term Evolution (NB-LTE), Narrowband Internet-of-Things (NB-IoT), or Long-Term Evolution Machine Type Communication (LTE-MTC).
  • LPWAN low power wide area network
  • NB-LTE Narrowband Long-Term Evolution
  • NB-IoT Narrowband Internet-of-Things
  • LTE-MTC Long-Term Evolution Machine Type Communication
  • the transceiver is always on, and in other cases, the transceiver may be activated when a data transfer is scheduled, requested, or activated. In some cases, the capability of the ambulatory medical device 1402 to communicate with the computing system may be activated during manufacture or before providing the device to a subject.
  • the subject or a user establishes or initiates establishing the direct end-to-end data connection with the computing system.
  • the subject may interact with a user interface to cause the ambulatory medical device to communicate with the cloud computing service.
  • the direct end-to-end data connection may be initiated or established without action by the subject or the user.
  • the direct end-to-end data connection may occur automatically at particular times or when the ambulatory medical device is in particular locations. This automatic connection may occur using information supplied to the ambulatory medical device at a time of manufacture, shipment, sale, or prescription to the subject.
  • the ambulatory medical device can communicate with the computing system without having access to a Wi-Fi network or a local area network (LAN).
  • LAN local area network
  • the ambulatory medical device may communicate using a cellular or other wide area network.
  • the interaction by the user with the ambulatory medical device may be relatively minimal or simple compared to traditional network communication.
  • a user may push a single button (e.g., an “upload” button) to trigger establishing of a connection with the cloud computing service and causing data to be provided from the ambulatory medical device to the cloud computing service.
  • the ambulatory medical device may be turned on and paired with the wireless wide area network (e.g., a cellular network) at the time of manufacture, or prior to being provided to a subject. Further, the ambulatory medical device may be authenticated with the networked-computing environment as part of the manufacturing process
  • establishing the direct end-to-end data connection may include determining that the ambulatory medical device is permitted to communicate with the computing system based at least in part on the device identifier.
  • establishing the direct end-to-end data connection may include determining that the ambulatory medical device is permitted to communicate with the computing system based at least in part on a device identifier associated with the ambulatory medical device.
  • the device identifier may be a unique identifier specific to the ambulatory medical device.
  • the device identifier may include or may be based on one or more of an Internet Protocol (IP) address, a Media Access Control (MAC) address, a serial number, or a subject identifier of a subject that receives therapy from the ambulatory medical device.
  • IP Internet Protocol
  • MAC Media Access Control
  • establishing the direct end-to-end data connection may include determining that the ambulatory medical device is permitted to communicate with the computing system based at least in part on the device identifier.
  • the device identifier may be initially provided to the networked-computing environment prior to provisioning of the ambulatory medical device to the subject.
  • the device identifier may be initially provided to the networked-computing environment as part of a manufacturing process for manufacturing the ambulatory medical device.
  • the request may include a device identifier associated with the ambulatory medical device.
  • the ambulatory medical device may be configured to at least identify a computing system 1406 of a networked computing environment 1412 based on a whitelist of one or more approved computing systems.
  • the whitelist may be stored in a memory of the AMD 1402 (e.g., a memory in the control and computing module of the AMD). Further, the whitelist may be configured during manufacture of the ambulatory medical device. For example, the whitelist may be configured with connection information to establish communication with one or more computing systems of a networked-computing environment. Further, the ambulatory medical device may be configured to at least obtain an address of the computing system from the whitelist and to establish a direct end-to-end data connection to the computing system of the networked-computing environment via a wireless wide area network using the address.
  • the whitelist may include unique identifiers, such as MAC addresses or static IP addresses that are associated with computing systems of the cloud services provider.
  • the ambulatory medical device may use a whitelist that identifies via a unique identifier (e.g., via an IP address, a MAC address, or a URL) permitted cloud servers or computing systems in networked computing environment.
  • a unique identifier e.g., via an IP address, a MAC address, or a URL
  • the cloud computing service may have a whitelist that uses unique identifiers to specify ambulatory medical devices and/or other computing systems (e.g., remote display systems) that are permitted to communicate with the cloud computing system.
  • all communication between the ambulatory medical device and the computing may be based on a secure data transmission method.
  • the ambulatory medical device may encrypt all data using an asymmetric key.
  • the therapy data may be encrypted before being transferred to the computing system.
  • AMD may have a public key and a private key stored in one of its memories permitting the AMD to encrypt data communications transmitted by the ambulatory medical device to the computing system.
  • AMD may transmit the public key along with the therapy data to the computing system.
  • the public key provided by the AMD and a private key stored on the computing system may permit the computing system to decrypt the data received from the ambulatory medical device.
  • the public key may timeout and a new public key may be obtained from the ambulatory medical device to facilitate decrypting subsequent communications from the ambulatory medical device.
  • the public key may be associated with a time-to-live (TTL) value.
  • TTL time-to-live
  • the public key may timeout and a new public key may be obtained from the ambulatory medical device to facilitate decrypting subsequent communications from the ambulatory medical device.
  • the secure data transmission may include generating a shared secret based at least in part on the public key and the private key.
  • decrypting the encrypted data comprises using the shared secret to decrypt the encrypted data.
  • shared secret may be established using public key exchange algorithm (e.g., Diffie-Hellman key exchange algorithm).
  • the computing system may be configured to transfer the data after receiving a request to transfer data stored on the ambulatory medical device to the computing system over the direct end-to-end data connection via the wireless wide area network. Responsive to receiving the request to transfer data stored on the ambulatory medical device to the computing system, the computing system may be configured to receive, via the direct end-to-end data connection.
  • the computing system may analyze the therapy data received from the ambulatory medical device and generate a therapy report. Further, the computing system may detect an alarm condition, based on therapy data analysis, and generate an alarm that may be provided to the subject, authorized user (e.g., healthcare provider). In some cases, the therapy data may trigger an automatic response by the computing system. For example, the AMD may determine that a medicament or another disposable is running low based on the received data and may automatically reorder the medicament or the disposable.
  • the computing system may periodically receive data from the ambulatory medical device based on a regular schedule. Alternatively, or in addition, the data may be received in response to a command or when the ambulatory medical device determines it is within a certain location. For example, when the ambulatory medical device determines it is within a subject's home or at a healthcare provider's office based on a local area network connection or based on a geolocation system (e.g., a global positioning system (GPS)).
  • GPS global positioning system
  • additional encrypted data is received from the ambulatory medical device on an intermittent basis. Alternatively, or in addition, additional encrypted data is received from the ambulatory medical device on a continuous basis for at least a time period.
  • the ambulatory medical device may be configured to transmit data as it is generated, or shortly thereafter, (e.g., in real or near real-time (e.g., within a few millisecond, seconds, or minutes of the data being generated)), or in bulk at specified periods of time. Transmitting the data in bulk at particular time periods may extend battery life, but may provide for less up-to-date analysis. Data can be made available on-demand by keeping the transceiver always on, but this may consume more power. Thus, the scheduling of data transfer may be balanced based on different considerations, such as: (1) power consumption and (2) need to share information with authorized users or systems.
  • the computing system may be used as a backup for the ambulatory medical device.
  • the ambulatory medical device can backup data to the computing system every night, when it is charging, or when it is in proximity to home or a physician's office (e.g., when subject is in waiting room, the device may upload data that the physician can then access).
  • the ambulatory medical device is replaced (e.g., for a new model or to replace a damaged device), the device can automatically synchronize with the computing system to obtain subject-specific configuration or therapy control data.
  • the therapy data comprises dose or dosage data corresponding to one or more doses of medicament provided by the ambulatory medical device to the subject. Further, the therapy data may comprise subject data corresponding to a medical or physiological state of the subject as determined by the ambulatory medical device.
  • the data provided to computing system may include any type of data that may be measured or obtained by the ambulatory medical device and may include a record of therapy provided by the ambulatory medical device.
  • the data may include a time that therapy was provided, an amount of medicament provided as part of the therapy, a measure of one or more vital signs of the subject, a measure of glucose levels (e.g., blood glucose levels) at different times for the subject, a location of the subject, and the like.
  • the therapy data may be used to track the use of disposables, such as insulin or other medicament, or insulin pump site kits.
  • the computing system may automatically order or reorder disposables at a particular time based on tracking the use of the disposable.
  • the reordering of the disposables may be initiated or performed from the ambulatory medical device (e.g., via a wireless wide area network or via a local connection through a separate electronic device).
  • the data transferred to the computing systems may comprise operation data corresponding to operation of the ambulatory medical device.
  • the data may further comprise error data corresponding to an error in operation of the ambulatory medical device.
  • the data, therapy data and/or the therapy report may be stored in a memory of the computing system and/or at a storage of the networked-computing environment.
  • the method may include converting the therapy data from one format to another format.
  • the method may include converting the therapy data from a format used to store and/or present data on ambulatory medical device to a format that can be stored or processed on the computing system.
  • the therapy data is converted from a machine-readable format to a human-readable format.
  • the data may be stored in a more easily interpreted format that can be understood by different types of users.
  • the data may be presented in one format for a healthcare provider (e.g., sensor readings), a simplified format for a subject or parent of a subject, other data formats for displaying data to different types of users.
  • the therapy data collected from different AMDs associated with plurality of subjects may be aggregated for a group of subjects based on their association with an institution or organization (e.g., a clinic, an insurance company, and the like)
  • an institution or organization e.g., a clinic, an insurance company, and the like
  • a therapy report based at least in part on the therapy data may be generated by the computing system.
  • the therapy report may comprise time-series therapy data relating to the therapy delivered by the ambulatory medical device over a particular time period.
  • the therapy report may be sent to AMD wherein the subject can see the report via a user interface (e.g., a touchscreen display).
  • a user interface e.g., a touchscreen display
  • the ambulatory device data and/or data generated by the computing system based on the ambulatory device data can be viewed on a secondary display system from the computing system.
  • a clinician or parent can access the data from their personal device.
  • the communication between the computing systems and the viewing device may be encrypted.
  • permission for sharing of end user data with a ‘follower’ (e.g., family member) or clinician may be granted or controlled by the end user (e.g., the subject or a guardian).
  • An association between a subject, a clinic, and/or an ambulatory medical device may be performed by association of a device serial number of the ambulatory medical device with the subject and/or clinic.
  • a user e.g., a subject, clinician, or parent
  • the computing system may be configured to at least receive a request from one or more display systems 1414 that are separate from the networked computing environment to access the therapy report, therapy data or other data received by or stored in the AMD.
  • the display system may be a computing system of a medical practitioner 1418 (e.g., such as a doctor or a nurse), a guardian of the subject 1420 (e.g., subject's parents), an authorized user 1422 (e.g., a user authorized by the subject such as spouse, relative, friend, and the like), a health care service provider 1424 , or a device of the subject 1416 (e.g., cell phone, personal computer, tablet, and the like).
  • a medical practitioner 1418 e.g., such as a doctor or a nurse
  • a guardian of the subject 1420 e.g., subject's parents
  • an authorized user 1422 e.g., a user authorized by the subject such as spouse, relative, friend, and the like
  • the display system can be a therapy data management system that analyses a therapy data associated with a specific type of health problem (e.g., data associated with managing diabetes) and provides useful information to the subject or an authorized user to monitor and manage the corresponding ailment.
  • a therapy data management system that analyses a therapy data associated with a specific type of health problem (e.g., data associated with managing diabetes) and provides useful information to the subject or an authorized user to monitor and manage the corresponding ailment.
  • the request may comprise an account identifier associated with a user that generated the request.
  • the account identifier may comprise a unique identifier associated with the subject.
  • the account identifier comprises a unique identifier associated with a user that is authorized to access the therapy report.
  • the user may or may not be the subject.
  • the method may further include associating the therapy data with the account identifier at a storage of the networked-computing environment.
  • the computing system may be configured to determine whether an account associated with the account identifier is permitted to view the therapy report. In some examples, account permissions may be granted and/or modified by the subject.
  • the subject can access an account at a networked computing environment 1412 , for example, a cloud service provider associated with the subject, and provide one or more identifiers associated with one or more other users to give them permission to access the subject's therapy data or report stored on the computing system.
  • a networked computing environment 1412 for example, a cloud service provider associated with the subject, and provide one or more identifiers associated with one or more other users to give them permission to access the subject's therapy data or report stored on the computing system.
  • the hardware processor may be configured to transmit the therapy report to the display system over an encrypted communication channel.
  • the method may include receiving an identity or identification information of one or more users that are authorized to access therapy data stored at the networked-computing environment.
  • a user or subject may authorize a clinician or other healthcare provider, a parent or guardian, or other users that the subject desires to have access to the therapy data.
  • the identity information of the one or more users may include any type of information that may identify the user or enable the user to be authenticated.
  • the identity information may include a name, unique identifier (e.g., social security number), an email, an address, a phone number, account information for the user at the networked-computing environment, or any other identifying information.
  • FIG. 15 is a flow diagram that illustrates an example method that may be used by computing system 1406 , to generate and share a therapy report based on encrypted therapy data received from an AMD 1402 .
  • the AMD 1402 may generate the encrypted therapy data using a public key and a private key.
  • the method may include establishing a direct end-to-end data connection 1502 to an ambulatory medical device, for example, via a wireless wide area network (WAN) using a Narrowband Long-Term Evolution (NB-LTE) transceiver included in the AMD 1402 .
  • WAN wireless wide area network
  • NB-LTE Narrowband Long-Term Evolution
  • the computing system may receive a public key 1504 (e.g., associated with encrypted data), from the AMD 1402 over the established connection.
  • the computing system may receive a request from the AMD 1506 to transfer data (e.g., therapy data) stored on the AMD 1402 to the computing system 1406 over the direct end-to-end data connection.
  • the computing system 1406 may use the device ID associated with the AMD 1402 to determine whether the AMD 1402 is authorized to transfer data to the computing system 1508 . If, based on the device ID, it is determined that the AMD 1402 is authorized to transfer data to the computing system, the encrypted therapy data may be transferred 1512 to the computing system.
  • the request may be denied 1510 .
  • the computing system may decrypt the encrypted therapy data 1514 using a private key (e.g., stored in a memory of the computing system) and a public key received from the AMD 1402 .
  • the therapy data may be used to generate a therapy report 1516 .
  • the decrypted therapy data and/or therapy report may be stored in a memory of the computing system 1406 .
  • the example method may further include receiving a request from a display system 1414 that is separate from the networked computing environment, to access the therapy report 1518 .
  • the request may comprise an account identifier associated with a user that generated the request.
  • the method may include determining using the account identifier to determine whether the account associated with the account identifier is permitted to view the therapy report 1520 .
  • the computing system determines that the account associated with the received account identifier does not have the required permission, the request will be denied 1524 .
  • the method may include transmitting the therapy report to the display system 1522 over an encrypted communication channel.
  • the method may further include determining that the therapy data or other data received from the AMD satisfy an alert threshold condition.
  • the computing system may send an alert to one or more display systems designated to receive alerts from the computing system.
  • alert threshold condition may be associated with the health condition of the subject.
  • alert threshold condition may include subject's glucose level is above or below a set value (hyperglycemia or hypoglycemia).
  • alert threshold condition may be associated with the operation of the AMD.
  • alert threshold condition may include the rate of therapy (e.g., the rate at which insulin is provided to a subject) being above or below a set value.
  • alert threshold condition may be associated with the temporal behavior of therapy data over a period of time.
  • the alert threshold condition may include the fluctuations or variations of the subject's glucose level being above a set value.
  • the alert threshold condition may be defined or set by health provider.
  • the health provider may change one or more alert threshold conditions based on the health condition of the subject.
  • FIG. 16 is block diagram, illustrating an example network and data flow configuration where an AMD 1602 , which is directly connected to a computing system 1606 (e.g., computing system within a cloud network 1610 ), may generate and send alerts 1616 (e.g., alert messages, alert signals, and the like) upon determining that data 1612 received from the AMD satisfies a threshold condition.
  • the computing system 1606 may be part of networked computing environment 1614 (e.g., a data center, networked computing system), or cloud network 1610 or cloud computing system of a cloud service provider.
  • the computing system may include one or more non-transitional memories and one or more hardware processors configured to execute the computer-executable instructions stored in one or more non-transitional memories.
  • the AMD may receive data from one or more medical sensors 1608 (e.g., analyte sensor, temperature sensor, heart beat sensor, and the like) and/or one or more environmental sensors (e.g., geolocation receiver, motions sensor, accelerometer and the like.). These sensors may be included in the AMD unit or may be connected to the AMD via a wired or wireless link.
  • medical sensors 1608 e.g., analyte sensor, temperature sensor, heart beat sensor, and the like
  • environmental sensors e.g., geolocation receiver, motions sensor, accelerometer and the like.
  • the display systems receiving the alert 1620 may be display systems that have already received therapy reports from the computing system 1606 .
  • a group of display systems may be selected and authorized by the subject, who is receiving therapy from the AMD, to receive alerts 1620 .
  • the display systems that may receive alerts 1620 from the AMD may include: a medical practitioner 1624 (e.g., such as a doctor or nurse), a guardian of the subject 1626 (e.g., subject's parents), an emergency service provider 1628 , an authorized user 1630 (e.g., a user authorized by the subject such as spouse, relative, friend, and the like), a healthcare provider 1632 , or a device of a subject 1622 (e.g., cell phone, personal computer, tablet, and the like).
  • the computing system 1606 may send an alert 1616 to the AMD 1602 .
  • the AMD 1602 may be configured to establish a connection to support continuous data transfer to the computing system 1606 for a given period of time (e.g., provided to the AMD by the subject), in order to capture any data that is generated over that period and satisfies an alert threshold condition.
  • the subject may request a continuous connection between AMD and the computing system when going for hike alone to make sure that if his/her health condition deteriorate during the hike, an alert is sent to authorized display systems.
  • a geolocation sensor e.g., a Global Positioning System (GPS) receiver
  • GPS Global Positioning System
  • proximity sensor can be used to enable location-activated features such as automatic upload of data at certain locations.
  • the ambulatory medical device may include or be connected to an accelerometer or a geolocation system. This velocity of the ambulatory medical device may be determined based at least in part on the accelerometer or geolocation system.
  • the computing system 1606 can provide intelligent alerts. For example, if the data indicates that a user is travelling at a high rate of speed (e.g., likely in a car) and the user's glucose level is low (e.g., below 55 mg/dl), the computing system may automatically alert emergency service providers 1628 that a subject is at risk of hypoglycemia and may be driving. Further, the computing system can provide a location of the subject to the emergency service provider 1628 .
  • the computing system can generate alerts based on a trend of the aggregated therapy data or based on therapy data that is an outlier to the aggregate therapy data or an outlier to a time-based average of the therapy data.
  • the geolocation sensor and/or a motion sensor can be used to detect velocity of a subject to enable intelligent motion-sensitive alerts. For example, if the subject is moving at 60 mph and experiences low glucose level, the system may enable a set of driving alerts and schedule possibly therapy in the future. The driving alerts may inform the subject to pull over immediately due to a risk of a hypoglycemic event. Further, an emergency responder may be informed of a subject location using based on information obtained from the geolocation sensor. If the subject is moving at 6-7 mph, exercise alerts may be enabled to, for example, alert the user to pause exercising and attend to low glucose level.
  • a motion sensor e.g., an accelerometer
  • the system can enable automatic notification to emergency services. Further, a determination of the subject's motion can be used to automatically adjust setpoint (e.g., raise setpoint during exercise). The activity level of the subject can be sensed and use to improve alerts and therapy.
  • setpoint e.g., raise setpoint during exercise
  • the cloud server can send a text message or call to a follower's and/or end user's phone or smart device in case the therapy data satisfies an alert threshold.
  • These messages may be provided from the cloud computing system to a third-party device in case roaming or disabling of the data plan on the ambulatory medical device occurs (e.g., no TCP/IP available).
  • the cloud computing service may send a text message or call 911 in case of a detected emergency.
  • the cloud server can track, for example, via GPS, the end user's most recent location and share that information with a follower and/or emergency personnel.
  • the cloud computing system may enable an end user to order and re-order medical supplies directly from the viewing device.
  • the computing system can generate notifications (e.g., generate a message when there is a risk of hypoglycemia). Further, more detailed processing in the cloud can result in improved recommendations (e.g., Tmax, setpoint, or other control parameters)
  • FIG. 17 is a flow diagram illustrating an example method that may be used by computing system 1606 , to generate and send alerts (e.g., alert messages, alert signals, and the like) to one or more authorized devices and to the AMD.
  • the method may include establishing a direct end-to-end data connection 1702 to an ambulatory medical device, for example, via a wireless wide area network (WAN) using a Narrowband Long-Term Evolution (NB-LTE) transceiver included in the AMD 1602 .
  • WAN wireless wide area network
  • NB-LTE Narrowband Long-Term Evolution
  • the direct end-to-end connection may be established for a given period of time set by the subject or an authorized user (e.g., a guardian of the subject).
  • the computing system may receive a public key 1704 , from the AMD 1602 over the established connection.
  • the computing system may receive a request from the AMD 1706 to transfer data (e.g., therapy data, medical sensor data or environmental sensor data) generated by the AMD 1602 to the computing system 1606 over the direct end-to-end data connection.
  • the request may include a time period during which AMD continuously transmits any data generated by the AMD 1602 or obtained from one or more sensors (e.g., environmental sensors 1604 or medical sensors 1608 ), to the computing system 1606 .
  • the time period for continuous data transfer from the AMD 1602 to the computing system 1606 may be provided by the subject or a guardian of the subject to the AMD.
  • the computing system 1606 may use the device ID associated with the AMD 1602 to determine whether the AMD 1602 is authorized to transfer data 1708 to the computing system 1606 . If, based on the device ID, it is determined that the AMD 1602 is authorized to transfer data to the computing system 1606 , the encrypted therapy data may be transferred 1712 to the computing system 1606 . If, based on the device ID, it is determined that the AMD 1602 is not authorized to transfer data to the computing system, the request may be denied 1710 .
  • the computing system 1606 may decrypt the received data 1714 using a private key (e.g., stored in a memory of the computing system 1606 ) and a public key received 1702 from the AMD 1602 .
  • the computing system 1606 may determine whether the received data (e.g., therapy data, medical sensor data or the environmental sensor data), satisfies a threshold condition 1716 .
  • the threshold condition may be provided to the AMD by the subject or an authorized user (e.g., a guardian of the subject).
  • the threshold condition may be provided by a healthcare provider.
  • the threshold condition may be stored in a memory of the AMD.
  • an alert may be generated and sent 1718 to one or more display systems 1618 that are authorized (e.g., by the subject or a guardian of the subject) to receive alerts.
  • the subject or the guardian may authorize one or more display systems 1618 to receive alerts by providing the account IDs of the one or more displays systems to the computing system 1606 or the networked computing environment 1614 .
  • the ambulatory medicament device may include a user interface (e.g., touchscreen interface or a non-touchscreen interface) that may present one or more user-interface screens to a user enabling the user to modify one or more therapy settings of the ambulatory medicament device, such as a quantity of medicament delivered when a condition is met or the condition that triggers the delivery of medicament to a subject.
  • the user may be a subject receiving medicament or therapy, or may be another user, such as a clinician or healthcare provider, or a parent or guardian.
  • ambulatory medicament devices that include a user interface
  • a setting is accidentally modified or is modified (intentionally or unintentionally) by a user that does not fully comprehend his or her action (e.g., a child or a user with a reduced mental capacity).
  • ambulatory medicament devices may accidentally have settings modified by inadvertent interactions with a user interface, such as may occur when an ambulatory medicament device is worn against the body of a subject.
  • This section relates to an ambulatory medical device (AMD) to prevent an inadvertent modification in medicament deliver, for example, in the event of a setting of the AMD being accidentally modified by a user or inadvertent interactions with a user interface.
  • AMD ambulatory medical device
  • the user may modify the control or configuration the AMD using a user interface.
  • the control or configuration of the AMD is accidentally modified through the user interface.
  • the user may transport the ambulatory medical device, there is a danger that the user will inadvertently activate input in the ambulatory medical device that initiates a therapy change input (e.g., by applying pressure on the ambulatory medical device that may be placed in the jacket pocket of the user).
  • the control and computing module (CCM) of the AMD may include a set of therapy change procedures 1818 implemented to prevent therapy change inputs 1820 that are inadvertent.
  • the therapy change procedures 1818 may be implemented as instructions stored in a memory of control and computing module 610 (e.g., the main memory 616 ) and executed by the processor 614 .
  • the therapy change input 1820 received from a subject 1816 , may be verified by the therapy change procedures 1818 before the AMD 600 provides the therapy change delivery 1804 . All the user interactions with the user interface module 1806 may be controlled and analyzed by the control and computing module 610 (CCM) via one or more therapy change procedures 1818 .
  • the subject 1816 may wake or unlock the AMD by interacting with a wake interface 1810 .
  • the wake interface 1810 can be any of the additional user interfaces mentioned above, configured to generate a wake input to the CCM 610 when detecting a pre-set user interaction.
  • the therapy change input 1820 can be an input provided by the subject 1816 to change a therapy that is currently being delivered to the subject 1816 .
  • the therapy change input 1820 may cause the insulin or glucagon infusion pump to start infusing an amount of insulin or glucagon into the subject 1816 .
  • the therapy change input 1820 may modify the rate of insulin or glucagon infusion into the subject 1816 .
  • the therapy change input 1820 may also cancel insulin or glucagon infusion into the subject 1816 from the insulin or glucagon infusion pump.
  • a wake input is sent to the control and computing module 610 wherein it imitates a wake control procedure 1826 that generates a wake signal to wake/unlock the user interface (e.g., a touch screen display).
  • a wake control procedure 1826 that generates a wake signal to wake/unlock the user interface (e.g., a touch screen display).
  • a user When in the wake and/or unlocked state, a user may interact with the touchscreen display 1812 , alphanumeric pad 1814 or other types of user interfaces that may be included in the user interface module 1806 , to obtain access to therapy change user interface.
  • the therapy change user interface may be activated by a first user interaction with the user interface (e.g., touchscreen display 1812 ).
  • the user interface module user interface module 1806 sends an input signal to the control and computing module 610 wherein it is analyzed by a therapy change control procedure 1828 . If it is determined that the first user interaction satisfies a set of predefined conditions, the therapy change control procedure 1828 generates a signal to the user interface module user interface module 1806 to activate the therapy change user interface.
  • the therapy change user interface may be limited based on the first user interaction.
  • the therapy change control procedure 1828 may send one of two signals to the user interface module user interface module 1806 .
  • the therapy change user interface may then unlock one of two different therapy change user interfaces that result in different options of therapy change selections for the subject 1816 .
  • a therapy change selection to make a significant therapy change such as dramatically increase the rate of insulin or glucagon infusion rate, requires a first user interaction that is different from the first user interaction that would be required for an insulin or glucagon infusion at a normal or prescribed rate.
  • the first user interaction may be a simple interaction (e.g., a simple gesture) that unlocks a therapy change user interface with therapy change selections that are limited.
  • Another first user interaction may be a complicated interaction (e.g., a series of complex gestures) that unlocks a therapy change user interface with therapy change selections that have no limits.
  • An example of this implementation may be useful for child users. The child user may perform the first gesture that is made up of a series of simple inputs to unlock therapy change selections that are limited. An adult user may perform the first gesture that is made up of a series of complex inputs to unlock the therapy change user interface with therapy change selections that have no limits.
  • the therapy change user interface may provide one or more control or configuration elements that enable the user to modify the control or configuration of the ambulatory medicament device.
  • the control or configuration element may include any type of user interface screen on the touchscreen, or other type of user interface in the non-touchscreen context, that enables or permits a user to change a configuration of the ambulatory medicament device.
  • This change in configuration of the ambulatory medicament device may relate to a change in the therapy provided or in the detection of a triggering event that causes therapy (e.g., medicament) to be provided to a subject.
  • the change in configuration may include a selection between one or more hormones that regulate glucose level (e.g., insulin or glucagon) of a user, an amount of the one or more hormones that regulate glucose level of the user.
  • a change to the configuration of the ambulatory medicament device is automatically and/or instantly recognized or implemented by the ambulatory medicament device, and/or transmitted to the ambulatory medicament device.
  • a confirmation of the change may be required before the change is implemented by or transmitted to the ambulatory medicament device.
  • This confirmation may be entered based on a second user interaction with a user interface (e.g., touchscreen display 1812 ).
  • a user interface e.g., touchscreen display 1812
  • the user interface module user interface module 1806 sends an input signal to the control and computing module 610 wherein it is analyzed by a therapy change control procedure 1828 . If it is determined that the second user interaction satisfies a set of predefined conditions, the therapy change control procedure 1828 implements the change to the configuration of the AMD.
  • the first and/or second user interactions may include the selection of an icon, a series of taps or inputs, one or more gestures (e.g., a linear swipe, an arcuate swipe, a circular swipe, or other simple or complex movement across the touchscreen), performing a pattern or sequence on the touchscreen (e.g., drawing an image), a multi-touch or multi-input interaction, a combination of the foregoing, or any other type of interaction with a touchscreen, or portion thereof.
  • the series of inputs may be any combination of touch movements, touch points, numerical characters, alphabetical characters, and other symbols.
  • Gesture interactions can be guided by visual indicia displayed or printed on the AMD.
  • the visual indicia can include animations that suggest or guide user interactions with a touchscreen.
  • the first user interaction can include an arcuate swipe around at least a portion of a generally circular icon or logo.
  • the first and/or second user interactions may include a predetermined sequence of numerical or alphabetical inputs.
  • a series of multiple inputs the range of parameters for an input may be dependent on other inputs in the series. For example, required start position of a touch movement may be dependent on the position of the previous touch movement.
  • the time that the series of inputs are entered may also be a part of the range of parameters. For example, a series of inputs may need to be entered in no less than 3 seconds or more than 3 seconds, and no more than 15 seconds or less than 15 seconds.
  • one or more of the interactions may include interacting with a sensor as an optical sensor (e.g., visible light or IR sensor), biometric sensor (e.g., a fingerprint or retinal scanner), a proximity sensor, a gyroscope, or a combination of accelerometer and gyroscope, and the like.
  • a sensor as an optical sensor (e.g., visible light or IR sensor), biometric sensor (e.g., a fingerprint or retinal scanner), a proximity sensor, a gyroscope, or a combination of accelerometer and gyroscope, and the like.
  • the second user interaction may be made through a wireless signal such as RFID or Bluetooth.
  • the second user interaction may include receiving a selection of an indicator box that correspond to either insulin or glucagon and receiving a predetermined sequence of numerical inputs in order to deliver the therapy change selection.
  • the type of user interaction that unlocks the touchscreen, provides access to a configuration screen, and/or confirms a change to the configuration of the ambulatory medicament device may be the same or may differ.
  • the system may have a time-out such that if no interaction occurs for a set period of time, the user interface will turn off and the therapy change request process has to start again. In one implementation of the time-out, if no interaction occurs for more than 30 seconds after the system is waked/unlocked before the second user interaction is received by the user interface, the user interface will be deactivated.
  • the ambulatory medicament device may begin operating with the changed configuration.
  • This operation may include triggering therapy based on the new configuration or providing therapy based on the new configuration.
  • the ambulatory medicament device may generate a dose control signal based at least in part on the modified configuration or control parameter, or may detect a trigger based at least in part on the modified configuration or control parameter that leads to the provisioning of therapy.
  • the changes made through the therapy change user interface are sent to CCM wherein the therapy change control procedure 1828 in CCM transfers the changes to the device and subject monitoring procedure 1824 .
  • the device and subject monitoring procedure 1824 may be implemented in the CCM 610 to monitor the status of the AMD (e.g., therapy delivery configuration) and the health condition of the subject 1816 (or a subject).
  • the subject monitoring procedure 1824 may receive information about a therapy change requested by a subject 1816 through a user interface (a touchscreen display 1812 or alphanumeric pad 1814 ) or information about subject's glucose level from the subject sensor 1808 .
  • the device and subject monitoring procedure 1824 may transmit the information pertaining a health condition of the subject and/or the AMD configuration, to the medicament dose control procedure 1822 .
  • the parameters in the medicament dose control procedure 1822 may be adjusted based on the changes and/or information captured by the device and subject monitoring procedure 1824 .
  • the medicament dose control procedure 1822 controls the medicament delivery interface 1802 by providing a medicament dose signal.
  • the medicament does control may be generated based on detected conditions or physiological characteristics of the subject (e.g., provided by the readings of the subject sensor 1808 ) and according to parameter values received from the therapy change control procedure 1828 .
  • the medicament delivery interface 1802 may provide a therapy change delivery to the user according to the information received by device and subject monitoring procedure 1824 .
  • the dose control signals may be produced based on time (e.g., medicament may be delivered on a periodic basis), one or more a command, indication that the subject is planning to engage or is engaging in a particular activity (e.g., eating a meal, exercising, sleeping, fasting, etc.), or any other factor that may relate to or cause the triggering of therapy (e.g., medicament delivery).
  • FIG. 19 is a flow diagram illustrating an example method that may be used by an AMD to allow a user to change the configuration of the ambulatory medicament device using a touch screen user interface.
  • the user may initiate the configuration change process by waking/unlocking the touch screen using a wake action.
  • the wake interface sends a wake input to CCM 1904 .
  • the wake procedure generates a wake signal 1906 that unlocks the touch screen 1908 .
  • the therapy change user interface is unlocked 1912 .
  • the user may change the therapy configuration 1914 .
  • the user may confirm the changes made, by providing a second gesture on the touch screen 1916 . Once the confirmation is received 1916 the requested changes will be implemented 1918 , and the ambulatory medicament device may begin operating with the changed configuration. In some examples, once the user confirms the changes made, a dose control signal may be sent to the medicament delivery interface 1802 that triggers a therapy change delivery to the subject.
  • the ambulatory medicament device may have a timeout feature.
  • the timeout feature may cause the ambulatory medicament device or the control device to enter a sleep or locked state after a period of time of inactivity by the user.
  • the timeout feature may cause the ambulatory medicament device or the control device to enter a sleep or locked state after a particular period of time regardless of whether the user is interacting with the ambulatory medicament device or control device.
  • a user may have a limited period of time to modify he configuration of the ambulatory medicament device.
  • the therapy change made by a user may trigger the delivery of a medicament according to the therapy change received and confirmed by a user. This therapy change delivery may occur after a set time from period from receiving the confirmation.
  • an alarm status indicator may be presented to the user via the user interface.
  • the alarm status indicator can be an alert message or an alert symbol.
  • the alarm status indicator may be related to a configuration change made by a user, a change in the status of the AMD not related to a user input, or the condition of the subject (e.g., detected by the subject sensor).
  • FIG. 20A is an illustration of the touchscreen display 2000 of an example AMD after the touch screen is waked/unlocked by a wake action of a user and before the first user gesture is received. Even while the touchscreen display is locked, the touchscreen display 2000 may display any images, animations, text, or other graphics.
  • the first gesture prompt 2006 displays to the subject 1816 the input required to unlock the therapy change user interface. Here, the first gesture prompt 2006 shows the subject 1816 that a touch movement that begins at the greater-than symbol and moves right across the “Unlock” text is the acceptable first gesture.
  • the refill status of the AMD 600 is shown in a graphic representation 2010 .
  • the graphic representation 2010 shows that the insulin cartridge in the AMD 600 is almost full.
  • a current glucose level 2016 is shown at the top of the touchscreen display 2000 , which can inform the subject 1816 of the need for a hormone that regulates glucose levels.
  • the touchscreen display 2000 also shows a graphic representation of a cartridge of glucagon 2024 .
  • the graphic representation of an alarm 2030 in the touchscreen display 2000 shows that an alert is set on the AMD 600 .
  • FIG. 20B is an illustration of an example touchscreen display 2038 that may prompt the user to enter a predetermined series of inputs for the first gesture or second gesture.
  • the touchscreen display 2038 may display touchable number keys 2040 .
  • the touchscreen display 2038 prompts the subject 1816 to enter the series of inputs that complete the first gesture or second gesture.
  • the text Enter Code 2042 prompts the subject 1816 to enter a predetermined or preselected numerical sequence as part of the first gesture or second gesture.
  • the numerical sequence being typed by the subject 1816 is displayed in field 2044 as it is entered as an aid to the subject 1816 .
  • the input 2046 of the touchscreen display 2038 shows that a touch movement of a swipe right across the bottom of the screen is required to complete the predetermined series of inputs for the first gesture or second gesture.
  • a Bluetooth connection symbol 2048 shows that the AMD 600 is paired or can be paired to another electronic device.
  • FIG. 20C is an illustration of an example therapy change user interface (in this case a touchscreen display 2002 ).
  • the touch screen display may the subject 1816 prompt to select a hormone that regulates glucose level.
  • the touchscreen display 2002 presents the subject 1816 with an option to select between two hormones.
  • the touchscreen display 2002 aids the subject 1816 by showing the selected hormone 2008 for the subject 1816 .
  • the selected hormone 2008 is “insulin Only”.
  • the subject 1816 is also given the options of selecting the hormone Glucagon Only button 2012 or both Insulin & Glucagon button 2004 to regulate glucose level. Once the subject 1816 selects between the one or more hormones that regulate glucose level.
  • the Next button 2014 may be selected to complete the therapy change selection or select more options.
  • the therapy change user interface prompts the subject 1816 to select an amount of the one or more hormones that regulate glucose level of the subject 1816 .
  • the subject 1816 may be prompted to select a glucose level and the ambulatory medical device 200 may choose the hormone and the amount of the hormone.
  • FIG. 20D is an illustration of another therapy change user interface on a touchscreen display 2018 .
  • the subject 1816 is given a multitude of options.
  • One or more options in the therapy change user interface allow the subject 1816 to make a therapy change selection.
  • Other options are related to the therapy change selection.
  • a Deliver Hormone button 2036 allows the subject 1816 to select a therapy change that delivers a hormone that regulates blood glucose to the subject 1816 .
  • a Test glucose button 2020 allows the subject 1816 to test the glucose level of the subject 1816 .
  • a Generate Report button 2022 generates a document that reports the therapy changes that have been delivered to the subject 1816 .
  • a Refill Cartridge button 2026 allows the subject 1816 to fill a cartridge in the AMD 600 with medicament.
  • An Upload to Cloud button 2032 allows the subject 1816 to transmit therapy change information to a cloud-based server.
  • a Sound Control button 2028 allows the subject 1816 to control the sounds emitted by the AMD 600 .
  • a Settings button 2034 allows the subject 1816 to manipulate other settings of the AMD 600 .
  • an alarm status indicator may be presented to the user via the user interface to alert the user about a change made or occurred in the AMD configuration.
  • the subject 1816 may make a therapy change input 1820 using the user interface and based on the procedure illustrated in FIG. 19 .
  • therapy change control procedure 1828 implements the therapy change
  • the AMD may alert the user that a therapy change is implemented.
  • the alert message or symbol may be presented on a user interface (e.g., touch screen display) before and/or during the therapy change delivery 1804 .
  • alarm indicator may inform the subject 1816 that a therapy change is about to occur. Any number of details of the therapy change may be displayed as part of the alert message or symbol.
  • the alarm status indicator may appear after the user unlocks or wakes the user interface using a wake action.
  • FIG. 21 is a flow diagram illustrating an example method that may be used by an AMD to generate an alarm status indicator.
  • the device and subject monitoring procedure (excused within CCM), may continuously monitor the status of the AMD (e.g., the user interface, different modules of the AMD and the like) as well as the health condition of a subject (e.g., using various subject sensors such as analyte sensors) 2102 .
  • the device and subject monitoring procedure may determine whether the received status information satisfies an alarm condition 2106 . If the received status information does not satisfy an alarm condition, no cation will be taken and device and subject monitoring procedure continuous monitoring the AMD and the subject.
  • the system search for a wake signal 2108 . If no wake signal is detected, the system waits for a wake signal to be received 2110 . Once a wake signal is received via one or more user interfaces or sensors, the CCM may generate a display of a touchscreen lock screen interface 2112 and display one or more alarm status indicators 2114 , corresponding to the detected alarm condition, on the lock screen.
  • the AMD may allow the user to provide a therapy change and then cancel the therapy change.
  • FIG. 22 is a flow diagram illustrating an example method that may be used to cancel a therapy change using a touchscreen interface.
  • the user may unlock the touchscreen display 2202 using a wake action and get access to a therapy change user interface 2204 (e.g., using a first gesture) and a therapy control element therein, where one or more therapy control elements may be displayed.
  • a therapy change user interface 2204 e.g., using a first gesture
  • a therapy control element therein, where one or more therapy control elements may be displayed.
  • an indication of a modification to a therapy control element may be received 2206 by the user interface followed by a confirmation of the modification made 2208 (e.g., a second gesture).
  • the corresponding control parameter may be changes from a first setting to a second setting 2210 .
  • the user may decide to cancel it, for example, after realizing that requested change is erroneous.
  • the user may provide a third gesture 2212 on the touch screen.
  • the therapy change procedure may restore the modified control parameter to the first setting 2214 .
  • the third gesture may a restore gesture.
  • the restore gesture may be a swipe gesture. In some examples the swipe gesture may be performed near or in a region of the therapy change user interface that is occupied by the therapy control element.
  • An example of a restore swipe gesture may be performed from a starting swipe position to an ending swipe position located closer to a left edge of the touchscreen than the starting swipe position.
  • the restore gesture is received on a different user interface screen than a therapy change user interface wherein one or more therapy control element are provided.
  • the restore gesture is performed in the opposite direction from a therapy change confirmation gesture that confirms the modification to the therapy control element.
  • the restore gesture in order to cancel a therapy change request, has to be provided within a set time period after the confirmation gesture is received by the user interface. In some such examples, during the set time period one or more dose control signals may be provided to the medicament delivery interface resulting in one or more therapy change deliveries.
  • the system may allow the user, to modify a therapy change before confirmation.
  • the user may modify a therapy control element for a second time to change the corresponding control parameter from a second setting to a third setting.
  • the third setting may be the same as the first setting. In some cases, the first setting or the third setting may be a default setting. In some cases, the first setting or the third setting may be a restore setting.
  • FIG. 23A is an illustration of a touchscreen display 2300 alerting the user that the delivery of one or more medicaments will occur.
  • the alert may be accompanied by sound or vibration effects.
  • the alert informs the subject 1816 a delivery of medicament will occur in 2 seconds 2302 .
  • the touchscreen display 2300 is further allowing the subject 1816 to perform a gesture to cancel the therapy change.
  • the gesture to cancel the delivery is a touch movement that starts at the less-than symbol 2304 and swipes left across the “Cancel” text.
  • a single gesture by the subject 1816 may cancel the therapy change.
  • input of the wake signal, the first gesture, the therapy change selection, and the second gesture are all required to cancel a therapy that is being delivered.
  • the user may be able to cancel a therapy change delivery triggered based on therapy change made by the user.
  • the user may get access to the user interface using a wake action and provide a gesture to cancel the ongoing therapy corresponding to a therapy change delivery.
  • FIG. 23B is an illustration of a touchscreen display 2306 showing that a medicament is being delivered to the subject 1816 .
  • the text Delivering 2308 informs the subject 1816 that a medicament is currently being delivered to the subject 1816 .
  • the progress bar 2310 is a graphic representation of the progress of the delivery. As shown in FIG. 23B , the delivery is only starting and zero progress has been completed.
  • the touchscreen display 2306 is allowing the subject 1816 to perform a gesture to cancel the delivery, which includes interrupting and discontinuing the delivery if it had already begun but has not yet been completed.
  • the gesture to cancel the delivery is a touch movement that starts at the less-than symbol 2312 and swipes left across the “Cancel” text.
  • the therapy change delivery 1804 may be canceled by an input by the subject 1816 .
  • the input to cancel a therapy change delivery 1804 may be any input such as a wake signal input or a series of touch inputs such as a gesture.
  • the AMD may support a therapy suspension and resumption procedure allowing a user to suspend all therapies or a subset of therapies for a period of time defined by the user as well as automatic resumption of one or more therapies at the end of the requested suspension period or when a threshold condition is met (e.g., a threshold condition associated with the health condition of the subject).
  • a threshold condition e.g., a threshold condition associated with the health condition of the subject.
  • inadvertent activation and/or resumption of therapy delivery can be dangerous (e.g., when the AMD is an insulin and/or glucagon infusion device).
  • the AMD may be configured to avoid inadvertent suspension or resumption of therapies.
  • inadvertent activations of suspensions of medicament delivery may be prevented by requiring a user to perform gestures to activate suspension on the ambulatory medical device. The gestures must be entered at a particular prompt to activate a therapy suspension.
  • One particular application of the therapy suspension with automatic resumption feature in an AMD can be in the field of diabetes drug delivery.
  • the may need the ability to suspend delivery of insulin during situations such as exercise, which has a blood glucose lowering effect.
  • Suspension of insulin delivery can prevent a subject from entering a hypoglycemic state (extreme low blood glucose), which carries severe complications.
  • a hyperglycemic state high blood glucose that may result in complications such as diabetic ketoacidosis or neurovascular complications
  • the user forgets to reactivate the drug delivery after exercise if the user forgets to reactivate the drug delivery after exercise.
  • the subject's glucose level may raise above or below a dangerous level during the period of exercise. In these situations, the automatic medicament delivery resumption may improve the health of the subject.
  • the AMD may suspend one or more therapy deliveries when the AMD receives an indication that therapy (e.g., delivery of medicament) is to be suspended.
  • the indication that therapy is to be suspended may be a command from a user.
  • the user is the subject, but the user may also include other users that may have a say or interest in the care of the subject.
  • the user may be a clinician or other healthcare provider, or a parent or guardian.
  • the indication that the therapy or medicament delivery is to be suspended may be a command received via an interface of the ambulatory medicament device or from another device that provides the user with an interface to request that medicament delivery be suspended.
  • the device may be a smartwatch, smartphone, laptop or desktop, or other control device that can communicate via a wired or wireless connection with the ambulatory medical device.
  • the indication that the therapy or medicament delivery is to be suspended may be received from the ambulatory medicament device itself. For example, if the quantity of medicament available to the ambulatory medicament device drops below a threshold (e.g., the cartridge or reservoir is empty or below a minimum dosage amount), a signal may be generated to suspend medicament delivery. In some embodiments, suspension of therapy occurs based on a loss of a sensor signal, such as the loss of a glucose level signal.
  • FIG. 24 illustrates the interconnection among modules and procedures involved in receiving, accepting and/or canceling a therapy suspension request, in an example AMD.
  • a request for suspending one or more therapies can be made by a subject 2414 by providing a user input 2418 (e.g., the start and stop time for therapy suspension, selecting the type of therapy that should be suspended, and the like), through a therapy suspension user interface provided by the user interface module 2404 .
  • the therapy suspension user interface sends the suspension request along with the corresponding information to CCM wherein the therapy suspension control procedure 2426 implemented in CCM, processes and sends a therapy suspension signal to the device and subject monitoring procedure 2422 .
  • the therapy suspension control procedure may include a therapy suspension request verification procedure to verify the therapy suspension request.
  • the device and subject monitoring procedure 2422 may be implemented in the control and computing module 2416 to monitor the status of the AMD (e.g., therapy delivery configuration) and the health condition of the subject 2414 (or a subject). For example, when the device and subject monitoring procedure 2422 receives the request for therapy suspension, it may send a signal to the medicament dose control procedure 2420 indicating that no does control signal should be send to the medicament delivery interface 2402 during the period request by the subject 2414 . In some cases, if during the suspension period, certain pre-set conditions are satisfied, the device and subject monitoring procedure 2422 automatically resumes the therapy delivery by sending a signal to the medicament dose control procedure 2420 .
  • the device and subject monitoring procedure 2422 may send a signal to the medicament dose control procedure 2420 indicating that no does control signal should be send to the medicament delivery interface 2402 during the period request by the subject 2414 . In some cases, if during the suspension period, certain pre-set conditions are satisfied, the device and subject monitoring procedure 2422 automatically resumes the therapy delivery by sending a signal to the medicament dose
  • the subject sensor 2406 may resume the medicament delivery to the subject 2414 by a sending a dose control signal to the medicament delivery interface 2402 .
  • the user may initiate a therapy suspension request starting with a wake action (e.g., received by the wake interface 2408 and processed by the wake control procedure 2424 ), that activates the user interface module 2404 .
  • a wake action e.g., received by the wake interface 2408 and processed by the wake control procedure 2424
  • the user may unlock a therapy suspension user interface where the information pertaining therapy suspension is provided.
  • the user may confirm the requested therapy suspension using a second interaction with the user interface.
  • the system may allow access to the therapy suspension user interface and accept the suspension request, only if the first and second interaction with the user interface are verified by the therapy suspension control procedure 2426 .
  • the therapy suspension control procedure 2426 may receive the request for suspension and suspension information from another device connected to the AMD 600 (e.g., through the communication module).
  • the suspension information provided by the user may include a set of parameters needed for a suspension.
  • the suspension information may include the dates and/or times for starting and ending the therapy suspension, threshold values needed to define a threshold condition that may trigger an early resumption of the therapy delivery, and the like.
  • suspension information may indicate that the suspension of therapy should happen at a particular time or after a particular event (e.g., after the next dose of medicament is delivered or after the condition of the subject reaches a particular state, such as the middle of a desired blood glucose range).
  • the threshold values may be associated with input provided by the subject sensor 2406 or other types of sensors that may be used to monitor one or more parameters associated with the health condition of the subject 2414 .
  • the parameters for a suspension may include the start and stop conditions for a suspension.
  • the start condition for a suspension may be a condition that, when met, activates a suspension. In some such examples, the start condition is met when a timer runs out.
  • the stop condition is a condition that, when met, ends the suspension. In one example, the stop condition is met when a timer runs out. In another example, the stop condition is met when a threshold is met.
  • a threshold may be related to a measurement taken by ambulatory medical device (e.g., by a subject sensor 2406 ), such as a glucose concentration of the blood of a user. The threshold may be met if the glucose concentration goes above, goes below, or matches a set concentration.
  • Multiple conditions may be set by the suspension request interface component. For example, a time condition and a threshold condition may be set simultaneously. A user may specify that a suspension will end after a set time. However, the suspension may end sooner than the set time if the glucose concentration of the user meets a threshold.
  • the request to suspend therapy may include an indefinite suspension period. In other words, the request may not include a time period specified by a user or an identity of a resumption condition.
  • the indication may include a request to temporarily suspend delivery of therapy for a defined period of time or until a further interaction or event occurs.
  • the resumption condition can include an expiration of time or an active event (e.g., a command or a determined condition of a subject).
  • the therapy to be suspended may include any type of therapy.
  • the therapy to be suspended may be the suspension of the delivery of medicament, which may include insulin, counter-regulatory agent (e.g., Glucagon), or both insulin and a counter-regulatory agent.
  • the ambulatory medicament device may be capable of and/or configured to administer multiple medicaments (e.g., both insulin and a counter-regulatory agent).
  • the request to suspend therapy may include a request to suspend one (e.g., insulin or the counter-regulatory agent) or both of the medicaments.
  • the interactions with the user interface may include the selection of an icon, a series of taps or inputs, one or more gestures (e.g., a swipe or other simple or complex movement across the touchscreen), performing a pattern or sequence on the touchscreen (e.g., drawing an image), a multi-touch or multi-input interaction, a combination of the foregoing, or any other type of interaction with a touchscreen, or portion thereof.
  • the series of inputs may be any combination of touch movements, touch points, numerical characters, alphabetical characters, and other symbols.
  • the first and/or second user interactions may include a predetermined sequence of numerical or alphabetical inputs.
  • a series of multiple inputs the range of parameters for an input may be dependent on other inputs in the series.
  • required start position of a touch movement may be dependent on the position of the previous touch movement.
  • the time that the series of inputs are entered may also be a part of the range of parameters.
  • a series of inputs may need to be entered in no less than 3 seconds or more than 3 seconds, and no more than 15 seconds or less than 15 seconds.
  • a visual guide may assist the user in generating the user interaction.
  • one or more arrows or images may be presented to the user to guide the user in providing the command to suspend the delivery of therapy.
  • one or more of the interactions may include interacting with a sensor as an optical sensor (e.g., visible light or IR sensor), biometric sensor (e.g., a fingerprint or retinal scanner), a proximity sensor, a gyroscope, or a combination of accelerometer and gyroscope, and the like.
  • a sensor as an optical sensor (e.g., visible light or IR sensor), biometric sensor (e.g., a fingerprint or retinal scanner), a proximity sensor, a gyroscope, or a combination of accelerometer and gyroscope, and the like.
  • the second user interaction may be made through a wireless signal such as RFID or Bluetooth.
  • the second user interaction may include receiving a selection of an indicator box that correspond to either insulin or glucagon and receiving a predetermined sequence of numerical inputs in order to deliver the therapy change selection.
  • the type of user interaction that unlocks the touchscreen, provides access to a therapy suspension user interface, or confirms a suspension request may be the same or may differ.
  • the system may have a time-out such that if no interaction occurs for a set period of time at each step during the therapy suspension request process, the user interface will turn off and the therapy suspension request process has to start again.
  • the time-out if no interaction occurs for more than 30 seconds after the system is waked/unlocked before the second user interaction is received by the user interface, the user interface will be deactivated.
  • FIG. 25 is a flow diagram illustrating an example method for receiving and implementing a suspension request, which may be implemented by an AMD.
  • the user may use a touchscreen interface to request and confirm a therapy suspension.
  • the AMD may wait for a first gesture on the touchscreen.
  • a therapy user interface may be activated 2506 where the user can request a therapy suspension and provide 2508 the suspension information (e.g., a start day/time and stop day/time and/or a resumption condition).
  • the AMD may wait for second gesture on the user interface 2510 .
  • the therapy suspension control procedure 2426 may determine if a set time has passed since receiving the therapy suspension request 2514 . If it is determined that a set time has passed since receiving the therapy suspension request, the request will be canceled and the touch screen will be locked 2516 . If it is determined that time from receiving the therapy suspension is less than a set time the AMD may wait for the second gesture to be received.
  • the AMD may automatically activate a therapy suspension user interface 2506 , without the need for a first gesture 2504 .
  • a gesture e.g., a first gesture
  • a second gesture may stop a suspension before any of the conditions of the stop parameter are met. This allows the user the versatility of being able to modify a suspension that has been activated.
  • FIG. 26 is an illustration of a plurality of screens 2600 that the ambulatory medical device may display when a user activates a therapy suspension user interface.
  • Screen 2602 shows a user interface that an ambulatory medical device may display to a subject 2414 .
  • the display may be a touchscreen display 2410 that can accept input that includes the first and second gestures.
  • the therapy suspension system (AMD 600 ) is not limited to the displays shown in FIG. 26 .
  • Various displays may communicate, to the subject 2414 , the same information shown in FIG. 26 .
  • the screen 2602 allows the subject 2414 to select various functions.
  • the pause button 2612 shown on screen 2602 is a function that suspends the delivery of a medicament to the subject 2414 .
  • the pause screen 2604 allows the subject 2414 to select a duration of the medicament suspension.
  • the AMD 600 may display various interfaces to allow the subject 2414 to select a duration of the medicament suspension.
  • the pause screen 2604 shows a simple interface, giving the subject 2414 one of two duration options.
  • the pause screen 2606 shows the subject 2414 the duration 2614 that the subject 2414 selected (e.g., in the figure the subject 2414 selected 1 hour. Thus, the medicament delivery is suspended for 1 hour after the suspension begins).
  • the pause screen 2606 has a prompt 2608 for the user to make a gesture to confirm the requested suspension before the medicament suspension begins. As shown by the prompt 2608 , the subject 2414 is being prompted to swipe right across the bottom of the screen. Once the subject 2414 performs the gesture to begin the medicament suspension, the suspension screen 2610 is displayed on the touchscreen. The suspension screen 2610 informs the subject 2414 that the medicament is paused.
  • the subject 2414 has the option of performing another gesture to unlock the ambulatory medical device.
  • the prompt 2616 for the subject 2414 to unlock the device forces the user to perform another swipe to execute more functions on the AMD 600 .
  • Suspending the medicament delivery may occur by not generating a dose control signal to deliver a dose of medicament.
  • suspending the medicament delivery may occur by sending a signal to the medicament pump to cease providing therapy or medicament to the subject.
  • the ambulatory medicament device may not immediately suspend therapy upon receiving a command to suspend therapy. For example, if the ambulatory medicament device is in the process of delivering medicament or determines that a condition of the subject indicates that medicament may soon be required to maintain the subject's condition (e.g., blood glucose) within a particular state (e.g., within a desired blood glucose range), the suspension of therapy may be delayed until at least such time that medicament is not being delivered, is predicted to not be required during the suspension period, or the next therapy has been delivered. In some such cases, the ambulatory medicament device may inform that user that the suspension of therapy is being delayed. Further, the ambulatory medicament device may indicate the reason for the delay.
  • a condition of the subject e.g., blood glucose
  • a particular state e.g., within a desired blood glucose range
  • the suspension of therapy may be delayed until at least such time that medicament is not being delivered, is predicted to not be required during the suspension period, or the next therapy has been delivered.
  • the ambulatory medicament device may inform
  • the user may be able to override the delay and request immediate suspension of therapy. For example, if the user is replacing the medicament cartridge, the user may override an indication that the suspension of therapy should be delayed. In some cases, the requested start time may be overridden by a determined condition of the subject.
  • the suspension of therapy or the suspension of the delivery of medicament may continue until a resumption condition occurs.
  • the suspension period may automatically end without action by the user or subject.
  • the resumption condition may include the expiration of a time period, a command from a user (e.g., the subject), detection that the ambulatory medicament devise satisfies a condition (e.g., that medicament has been refilled), that the condition of the subject meets certain criteria (e.g., the subject's glucose level drops below a threshold range or rises above a threshold range), or any other condition that may satisfy the reason for suspension of therapy or that overrides the request for suspension of therapy.
  • the drug delivery device may be configured to automatically resume drug delivery when a glucose threshold is reached or exceeded. This threshold could be set to 300 mg/dl for example.
  • the resumption condition may include detection of an impending risk of hypoglycemia or hyperglycemia, or a hypoglycemia or hyperglycemia event. Further, the resumption condition may include a meal announcement, or an “exercise concluded announcement,” a motion sensing event, a pause of other administered medicament, a conclusion of an undefined suspension length (e.g., during cartridge change), a speed-based resumption event, a location-based resumption, a remote resumption in case of an emergency (e.g., commanded from caregiver admin software or clinician), or any other type of resumption event. In some cases, the resumption condition can include a combination of criteria.
  • automatically resuming therapy may include discontinuing the suspension of therapy before the expiration of the suspension period. For example, if a condition that caused therapy to be suspended is resolved prior to the expiration of the suspension period, therapy may be resumed.
  • the ambulatory medicament device may confirm that one or more additional condition of the ambulatory medicament device are satisfied before therapy is resumed. For example, if the ambulatory medicament device determines that medicament has not been refilled or if there is a problem with the refill (e.g., cartridge is incorrectly installed), the ambulatory medicament device may continue to maintain the suspension of therapy despite the trigger to resume therapy.
  • a resumption condition provided by the user
  • the ambulatory medicament device may confirm that one or more additional condition of the ambulatory medicament device are satisfied before therapy is resumed. For example, if the ambulatory medicament device determines that medicament has not been refilled or if there is a problem with the refill (e.g., cartridge is incorrectly installed), the ambulatory medicament device may continue to maintain the suspension of therapy despite the trigger to resume therapy.
  • a therapy suspension may be ended if a third interaction with a user interface (e.g., a gesture) is detected.
  • the third user interface interaction may be detected by the user interface module 2404 and sent to the therapy suspension control procedure 2426 . If the therapy suspension control procedure 2426 verifies that third interaction with the user interface is a predetermined third user interface interaction, it may send a signal to the device and subject monitoring procedure 2422 to activate the medicament dose control procedure 2420 .
  • This allows the user the versatility of being able to end a suspension that has been activated, during the suspension period set by the user before the confirmation (second interface with the user interface).
  • a user may decide to end a therapy suspension to modify one or more suspension conditions set prior to activation of the current therapy suspension. In some examples, user may decide to end a therapy suspension due to change in user's health condition not included in one or more therapy resumption conditions provided before activating the current therapy suspension.
  • FIG. 27 is a flow diagram illustrating an example method of resuming a suspended therapy that may be implemented by an AMD.
  • the AMD suspends one or more therapies selected for suspension 2704 at suspension initiation time received as part of the suspension information.
  • therapy suspension control procedure 2426 deactivates the medicament dose control procedure 2420 using the device and subject monitoring procedure 2422 .
  • the therapy suspension control procedure 2426 continuously monitors the system clock and the subject and device condition (e.g., using medicament dose control procedure 2420 ).
  • the therapy suspension control procedure 2426 determines that the time passed since the suspension initiation is less than the requested suspension time period 2706 and none of condition for resumption has been met 2708 , the therapy suspension continues.
  • the therapy suspension control procedure 2426 may check other AMD or subject conditions (not included in the therapy suspension information), in order to determine whether the therapy delivery can be safely resumed 2710 . If it is determined that the therapy delivery cannot be safely resumed, an alert message will be sent to the user interface to inform the about the reason for such determination 2714 . If it is determined that the therapy delivery can be safely resumed, the one or more suspended therapies will be resumed 2712 .
  • FIG. 28 is an illustration 2800 of a plurality of screens that may be displayed, for example, on a touchscreen display when a subject 2414 resumes a suspended therapy.
  • Screen 2802 informs the user that the delivery of medicament is currently in a suspended mode.
  • the screen 2812 also shows the subject 2414 the current glucose concentration of the blood of the subject 2414 .
  • the AMD 600 may display various vital measurements that are useful to the subject 2414 .
  • the medicament suspension ends if the glucose concentration of the blood of the user meets or passes a threshold.
  • the interface screen 2804 allows the subject 2414 to select and execute various functions on the AMD 600 .
  • the resume button 2814 is a function that ends a medicament suspension.
  • the AMD 600 displays a resume screen 2806 .
  • the resume screen 2806 has a prompt 2816 that prompts the subject 2414 to perform a gesture.
  • the subject 2414 receives a prompt 2816 in the resume screen to swipe right across the bottom of the resume screen 2806 .
  • the requirement to perform the gesture to resume medicament delivery prevents the subject 2414 from inadvertently resuming medicament delivery in the AMD 600 .
  • the resumption screen 2808 shows the subject 2414 that the regular medicament delivery has resumed.
  • the AMD 600 may display a lock screen 2810 .
  • the lock screen 2810 prevents the subject 2414 from inadvertently executing more functions on the AMD 600 .
  • the AMD 600 must receive a second gesture to end the suspension before the one or more conditions to end the suspension are met.
  • the purpose of the second gesture is to ensure that the subject 2414 does not inadvertently end the suspension.
  • the second gesture may be simple or complex.
  • the ambulatory medicament device may determine whether a dose of medicament should be supplied to the user based on a control algorithm used by the ambulatory medicament device to control the provisioning of medicament to the subject. For example, the therapy suspension control procedure 2426 may determine a resumption condition has been satisfied or receive a user input from the user interface module 2404 (a third interaction with a user interface) indicating that therapy suspension should be ended.
  • the therapy suspension control procedure 2426 may send a signal to the device and subject monitoring procedure 2422 to activate the medicament dose control procedure 2420 . If medicament is to be supplied, the medicament does medicament dose control procedure 2420 may generate and send a dose control signal to the medicament delivery interface 2402 .
  • the ambulatory medicament device may alert the user and/or the subject that therapy is being resumed. This alert may occur before generating a dose control signal and/or after a resumption condition is satisfied (e.g., a suspension time expires).
  • a resumption condition e.g., a suspension time expires.
  • the user may request that the suspension of therapy end early. The user may request the early resumption of therapy be interacting with the aforementioned user interface using one or more of the previously described interaction methods (e.g., gestures or taps).
  • An ambulatory medicament device such as, but not limited to, an insulin pump, that provides life-saving treatment to subjects or subjects based on the condition of the subject, may include a user interface (e.g., a touchscreen display) that lets a user to modify the settings of the ambulatory medicament device.
  • the setting may include, but not limited to, a condition that triggers the delivery of medicament to a subject, the quantity of medicament delivered when a condition is met, type of the medicament and the like.
  • the setting may also include features of the AMD that may not be directly related to the medicament delivery (e.g., the screen brightness, an alarm sound, and the like).
  • certain authorized users e.g., a healthcare provider
  • some other settings other authorized users e.g., the subject, a guardian or parent of the subject.
  • a healthcare provider can modify the settings of the ambulatory medicament device.
  • a non-healthcare provider modify at least some settings of the ambulatory medicament device.
  • changing the medicament cartridge may include interacting with a user interface and/or one or more settings of the ambulatory medicament device.
  • Another example of when it is desirable for a non-healthcare user (e.g., a subject, parent, or guardian) to modify settings of the ambulatory medicament device is when the initial settings of the ambulatory medicament device are not providing the desired effect (e.g., sufficient medicament, too much medicament, providing the medicament too slowly or too fast, etc.).
  • the desired effect e.g., sufficient medicament, too much medicament, providing the medicament too slowly or too fast, etc.
  • normal maintenance of the ambulatory medicament device and/or subject may require interaction with the ambulatory medicament device settings and/or controls.
  • negative consequences may being to occur when an ambulatory medicament device remains connected to a subject at the same site for more than a threshold period of time (e.g., for more than 2-3 days, more than 5 days, more than a week, etc.).
  • the ambulatory medicament device may need to be periodically moved from one site on the subject to another site on the subject (e.g., from left-side to right-side, from arm to leg, from stomach to back, etc.).
  • the change in site location may require interaction with settings of the ambulatory medicament device (e.g., pausing operation until the site change is completed).
  • a healthcare provider e.g., the subject receiving therapy, a parent, or a guardian
  • a child subject or otherwise
  • a user below a particular age have access to ambulatory medicament device settings that could cause harm to the subject if modified.
  • the user may be a subject receiving medicament or therapy, or may be another user, such as a clinician or healthcare provider, or a parent or guardian of the subject.
  • the passcode required for changing one or more setting via an intermediary device may be different that the passcode required for changing the same settings directly using the AMD's user interface.
  • One solution to regulating access to settings of the ambulatory medicament device is to implement a lock feature to require that a user provide a passcode, a passcode, or other information before the user is permitted to modify a setting of the AMD, such as a control parameter.
  • a passcode can be substituted for a passcode or any other type of secret or semi-secret information.
  • the AMD when the AMD is in the locked state, it may continue delivering therapy to the subject at the same rate as unlocked state.
  • the lock feature may be activated by default or may be activated by a user.
  • the lock feature can be enabled through a setting in a control menu of the AMD device provided on a user interface (i.e., touchscreen display).
  • the setting may include an on/off toggle (e.g., a software interface element or a hardware interface element) so when the toggle is on, a passcode (e.g., 4 to 8 numeric digits) may be required.
  • a passcode e.g., 4 to 8 numeric digits
  • the passcode e.g., a 4 to 8 numeric digit code
  • the user may program the ambulatory medicament device with a user passcode selected by the user.
  • the user passcode may be set in response to a passcode change request.
  • a user passcode may expire.
  • a user may be required to generate a new passcode after the previous passcode expires or before the previous passcode is permitted to expire.
  • the ambulatory medicament device may periodically generate a new passcode (e.g., an override passcode), or may generate the passcode at a time when a user supplies the passcode.
  • the user interface element used for accessing a user interface that enable changing one or more settings of the AMD may differ from the user interface for modifying the control parameters associated with that setting.
  • a keypad may be used to enter a passcode for unlocking a user interface for changing a control parameter and a touchscreen may be used to modify the control parameter.
  • the user interface screen may look and function the same as if the lock feature were not enabled. If the lock feature is enabled, when a visual guide for unlocking the device (such as, for example, a linear unlock slider, an arcuate unlock slider, or another unlock user interface element) is activated, a passcode entry interface (e.g., a keypad user interface element) may be displayed. If either the user passcode or the global override passcode is entered, the user interface may proceed as normal. Otherwise, the user interface may revert back to the original lock screen.
  • a visual guide for unlocking the device such as, for example, a linear unlock slider, an arcuate unlock slider, or another unlock user interface element
  • a passcode entry interface e.g., a keypad user interface element
  • the user action that permits a user to change one or more settings of the AMD may be different from the wake action that activates a user interface.
  • a wake action may be used to activate a touchscreen display that may display a plurality of user selectable elements some of which may be accessible without a passcode.
  • a subset of the user selectable elements for example those allowing the user to change therapy control parameters, may require a passcode.
  • access to each user parameter control element may require a different passcode.
  • providing a passcode may to an AMD in locked state, may directly enable access to a subset of control parameter elements.
  • the passcode may be set by the user enabling the user to select a passcode the user is more likely to remember.
  • the passcode may be set by the user enabling the user to select a passcode the user is more likely to remember.
  • the passcode may not remember the passcode. Due to the nature of the device (e.g., a device that may provide life-saving treatment), it is desirable that certain users not be restricted from accessing particular settings of the ambulatory medicament device, and be able to quickly (e.g., within seconds, minutes, prior to a next therapy event, or before harm may occur to the subject) obtain access to the particular settings when required.
  • embodiments disclosed herein include an ambulatory medicament device that includes an override passcode that enables access to the ambulatory medicament device (or control settings thereof) regardless of whether the user passcode is provided.
  • the passcode or the override passcode can be a series of taps, series of inputs, a complex or a simple gesture (e.g., a swipe or other movement across the touchscreen),
  • the series of inputs may be any combination of touch movements, touch points, numerical characters, alphabetical characters, and other symbols.
  • the time that the series of inputs are entered may also be a part of the range of parameters. For example, a series of inputs may need to be entered in no less than 3 seconds or more than 3 seconds, and no more than 15 seconds or less than 15 seconds.
  • One example of the complex gesture is a swipe.
  • the passcode or the override passcode can be a complex or a simple gesture (e.g., a swipe or other movement across the touchscreen), performing a pattern or sequence on the touchscreen (e.g., drawing an image), a multi-touch interaction, a combination of the foregoing, or any other type of interaction with a touchscreen, or portion thereof.
  • a complex gesture is entering a predetermined sequence of touches.
  • the passcode may include a quiz or set of questions,
  • the ambulatory medicament device may be configured to receive therapy settings or modifications to therapy settings from an intermediary device via a communication connection. In some cases, this feature may be supported in addition to providing the user with option of modifying one or more settings with a user interface of the AMD.
  • the communication connection between the intermediary device and the AMD may be a direct connection via, for example, Bluetooth®, or a connection via a network, such as over a local area network or a wide area network.
  • the ambulatory medicament device may include a wireless transceiver, such as an NB-LTE transceiver, a Wi-Fi transceiver, or a Bluetooth transceiver.
  • the intermediary device that provides the user with a user interface to modify settings of the AMD, include any type of device (e.g., a computing device) that can communicate with an ambulatory medicament device.
  • the intermediary device may be a laptop or desktop computer, a smartwatch, a smartphone, or a hardware control device that may be configured to interact with the ambulatory medicament device.
  • Embodiments disclosed herein are applicable regardless of whether the user interface for modifying therapy settings or the configuration of the ambulatory medicament device is generated or presented by the ambulatory medicament device to the user or via another device.
  • a user may provide a user-generated passcode or an override passcode via an interface of the computing device.
  • the computing device may then provide the user-generated passcode or the override passcode to the ambulatory medicament device via the network connection between the devices.
  • certain intermediary devices may have access to user interfaces that may be used to change one or more settings (e.g., therapy settings) of the AMD.
  • the smart phone of a guardian or a parent of the subject may be used to change one or more settings of the AMD while the AMD is in the locked state.
  • the AMD may be configured to receive a passcode from or via a computing systems (e.g., a cloud computing system).
  • the AMD may receive passcode through a direct end-to-end connection (e.g., a wireless connection over a wide area network) stablished with the computing system.
  • another computing device e.g., a smartphone, a laptop, a personal computer, and the like
  • the user can obtain access to the user interface that permits modification of the control parameter by supplying an override passcode.
  • the override passcode may be a universal fixed passcode (e.g., an 8-digit override passcode) that can be used instead of the user set passcode.
  • the override passcode can be stored in the ambulatory medicament device at the time of manufacture and may be shared among multiple ambulatory medicament devices (e.g., a global override passcode), or may be unique to a particular ambulatory medicament device.
  • the override passcode may be managed by the manufacturer or by a third-party service. To obtain the override passcode, the user may contact the manufacturer or passcode managing service.
  • enabling the passcode may exist to prevent a user with a diminished mental capacity (e.g., a child) from modifying settings of the ambulatory medicament device.
  • security may be less of a concern and any user can contact the manufacturer or passcode managing service to obtain the override passcode.
  • a single global override may be used for all devices produced by the manufacturer.
  • a level of security may be desired.
  • the user may be required to provide a serial number of the ambulatory medicament device.
  • each model or each unit of the ambulatory medicament device may have a different override passcode. The user may provide authorization information and a serial number of the ambulatory medicament device to the manufacturer or passcode managing service to obtain the override passcode.
  • the ambulatory medicament device may periodically generate a new override passcode or may generate an override passcode at a time when a user supplies the passcode.
  • the ambulatory medicament device may use the same parametric values to generate the override passcode as another device may use thereby ensuring a match between the override passcodes.
  • the override passcode can be obtained regardless of whether a user is able to contact a manufacturer or other passcode managing service.
  • the user may generate the override passcode without access to a network or phone using, for example, a computing device that can access a common parameter value as the ambulatory medicament device.
  • the override passcode may change over time or be a rotating passcode.
  • the override passcode may change every thirty seconds, every minute, every hour, etc.
  • the override passcode may be determined from an algorithm executed by an application.
  • the ambulatory medicament device may store a copy of the algorithm in a memory of the ambulatory medicament device and may execute the algorithm to determine the override passcode that is currently valid.
  • a copy of the algorithm may be executed by another computing device accessible by the user.
  • the output of the algorithm may be based on a value that is commonly accessible by the ambulatory medicament device and the copy of the algorithm accessible by the computing device.
  • the output of the algorithm may be generated based on a time, a user identifier, a provided value, or any other factor that may be used to repeatedly generate the same output.
  • the override passcode may be calculated based on a combination of factors.
  • the override passcode may be calculated based on a portion of a serial number or model number for the ambulatory medicament device and the time.
  • the determination of the override passcode may be calculated by the ambulatory medicament device, a computer server, and/or an application on a user device.
  • the override code can be automatically received by the ambulatory medicament device. Thus, a user may not need to see or enter the override code.
  • the override code may be transmitted to another device of the user (e.g., a smartphone or laptop). For example, the override code can be texted to a user's smartphone. In some cases, the override code may be received in a coded manner that may not be understandable by a child or user with diminished mental capacity.
  • the override passcode may be linked to a location.
  • the override passcode may only be enterable at a healthcare provider's office or at the subject's place of residence.
  • the determination of the location of the ambulatory medicament device may be based on a geolocation system (e.g., a Global positioning System (GPS)) available to the ambulatory medicament device.
  • GPS Global positioning System
  • the passcode may provide a second level of security in addition to other interactions with the user interface (e.g., a first and a second gesture on a touchscreen display) that may be used to change the therapy settings and/or accept the change made to a therapy setting.
  • the passcode may be used instead of other interactions with the user interface (described above).
  • interacting with the user interface may cause the ambulatory medicament device, or other device that can modify a control of the ambulatory medicament device, to present a passcode input screen to the user.
  • the user may enter the passcode to unlock additional user interface features including, for example, a user interface that enables the user to modify at least one control parameter of the ambulatory medicament device.
  • the control parameter can be modified based on an interaction with a parameter control element of the user interface. Further, modification of the control parameter may cause modification of the generation of a dose control signal that is generated by a control algorithm based at least in part on the control parameter.
  • the ambulatory medicament device may have an advanced therapy screen, or other user interface, that permits a healthcare provider, or other user, to obtain additional details relating to therapy provided by the ambulatory medicament device.
  • the advanced therapy screen may generally be intended for a knowledgeable user, such as a clinician, in some cases, any user may obtain access to the advanced therapy screen.
  • the advanced therapy screen may permit the healthcare provider to modify control parameters that may not be modifiable by other users.
  • the healthcare provider may be able to control parameters that relate to the calculation of a rate of insulin accumulation, the rate the insulin diminishes within the blood of the subject, the setting of a glucose setpoint, an aggression level or factor of therapy relating to an amount of insulin provided when the subject's glucose level is outside the setpoint range, or when the insulin reaches a point of maximum concentration within the blood of the subject (e.g., T max ).
  • T max a point of maximum concentration within the blood of the subject
  • Access to the advanced therapy screen may be limited by requirement of a passcode, which may be referred to as a clinician passcode to distinguish it from the user-generated passcode and/or the override passcode.
  • This clinician passcode may or may not be user-generated.
  • the clinician passcode may be a separate passcode from the user-generated passcode that permits access to the non-advanced therapy screen interface.
  • the clinician passcode may be separate from the override passcode that permits a user to override the user-generated passcode to obtain access to the non-advanced therapy screen interface.
  • the clinician passcode may be used as an override passcode.
  • the clinician passcode can be valid for period of time (e.g., set by a subject or another authorized user such as the guardian or apparent of the subject). For example, the clinician passcode may be valid for a day, a week or a month. In some examples, the AMD may allow certain authorized users to terminate the clinician access at any time.
  • access to the advanced therapy screen may be limited to a particular period of time. After the time period expires, the ambulatory medicament device may automatically restrict access to the advanced therapy screen. In some cases, the window of access may be extended. For example, if the healthcare provider is continuing to interact with the advanced therapy screen, the screen may remain accessible.
  • the advanced therapy screen may provide additional features. For example, while a user may be able to indicate that an amount of insulin provided for a meal or as a correction factor should be higher or lower, the healthcare provider may be able to specifically adjust the amount of insulin. Moreover, while a user's direction may or may not be followed depending, for example, if the request exceeds a threshold or may cause blood glucose to not satisfy a setpoint range, an indication provided via the advanced therapy screen may be followed regardless, or may have a wider range or different threshold that may control whether the instruction is followed. Further, the advanced therapy screen may be used to temporarily pause therapy and/or may prevent subject access.
  • the manufacturer of the ambulatory medicament device may provide a remote unlock signal that can be used to unlock access to the ambulatory medicament device and/or to an advanced therapy screen of the ambulatory medicament device.
  • the passcode may be desired to prevent particular users from inadvertently changing certain control parameters of the ambulatory medicament device.
  • features of the ambulatory medicament device that do not affect therapy may remain accessible to a user when the ambulatory medicament device is in a locked state.
  • a user may be able to access therapy history, screen brightness settings or colors, or any other feature that is unlikely to harm a subject if modified in a particular manner.
  • the passcode feature is generally to prevent control parameter changes, the ambulatory medicament device may provide therapy and continue to provide therapy at the same rate and under the same condition, whether or not the ambulatory medicament device is locked or unlocked.
  • the ambulatory medicament device validates the passcode.
  • the passcode may be validated by comparing the received passcode to a passcode stored in a memory of the ambulatory medicament device or generated by the ambulatory medicament device. If the passcode received from the user is successfully validated, the user may be granted access to a user interface to modify one or more control parameters. In some cases, the user may be requested to re-enter a passcode to confirm a change to a control parameter. In some examples, the user may be requested to provide a gesture on a touchscreen to confirm a change to a control parameter.
  • the ambulatory medicament device may prevent access to the user interface to modify the one or more control parameters.
  • the user interface that presents the user with the ability to enter the passcode may permit the user a particular number of tries or a particular number of tries within a particular time period to enter the user passcode. If the correct user passcode is not entered within the provided number of tries or within the particular time period, the user interface may enter a lock state (e.g., the screen will be turned off) and prevent further attempts to enter a passcode for at least a period of time. In some cases, the user passcode option may be indefinitely locked or blocked.
  • control parameters of the ambulatory medical device may only be accessible if the override passcode is provided.
  • a user passcode of a different user may be used to provide access to the control parameters of the ambulatory medical device.
  • the user interface may block any attempt to change the override passcode for at least a period of time.
  • a user may deactivate the passcode feature of the ambulatory medicament device. Deactivating the passcode feature may require use of a separate passcode or the override passcode in addition to the user passcode.
  • the passcode may be optional or omitted based on the computing device connected to the ambulatory medicament device. For example, if the end-to-end connection is established between a smartphone registered to a particular user (e.g., a parent of the subject), the ambulatory medicament device may unlock automatically without requiring a passcode. In other cases, the smartphone, or other computing device, may automatically provide the user-generated passcode or the override passcode to the ambulatory medicament device upon establishing a connection. In some cases, the ambulatory medicament device may automatically be unlocked when connected to a charger or when in a particular geographic area. For example, a geo-fence may be configured in one or more locations, such as the subject's house or the clinician's office.
  • the ambulatory medicament device may automatically be unlocked. Similarly, when the ambulatory medicament device determines that it is not within the geo-fenced region, it may automatically be locked.
  • the determination of the location of the ambulatory medicament device may be made based on a geo-location system, such as the Global Positioning System (GPS).
  • GPS Global Positioning System
  • the user interface screen may be turned off or may accept only the global override passcode
  • FIG. 29 is a block diagram illustrating the interconnection among modules and procedures in AMD involved in changing the settings of the AMD.
  • one or more settings of the AMD may be changed using a setting change input 2916 to one or more parameter control element parameter control elements 2930 / 2934 / 2938 presented on one or more setting user interface screens 2928 / 2932 / 2936 provided by the user interface module 2902 .
  • access to one or more setting control screens 2928 / 2932 / 2936 and/or one or more parameter control element 2930 / 2934 / 2938 may be protected by a passcode.
  • the user may provide a passcode input 2918 (e.g., a user generated passcode or an override passcode), via the user interface module 2902 (e.g., using a touchscreen display 2906 or alphanumeric pad 2908 ).
  • a passcode input 2918 e.g., a user generated passcode or an override passcode
  • the user interface module 2902 e.g., using a touchscreen display 2906 or alphanumeric pad 2908
  • the user 2910 may provide a passcode 2940 using an intermediary device (e.g., a laptop, a smart phone and the like) that is connected to the AMD (e.g., via a wireless link).
  • an intermediary device e.g., a laptop, a smart phone and the like
  • the access to one or more setting user interface screens 2928 / 2932 / 2936 and/or parameter control element parameter control elements 2930 / 2934 / 2938 may be managed by setting change procedures 2912 stored in a memory in the control and computing module of the AMD.
  • a hard processor may execute the machine readable instructions associated with the setting change procedures 2912 .
  • the option to provide a passcode may become available, when the user 2910 performs a wake action on a wake interface 2904 .
  • the wake control procedure 2922 of the CCM determines that a valid wake action is performed, it may present selectable elements associated with the setting user interface screens 2928 / 2932 / 2936 , for example, on a touchscreen display.
  • the first screen presented on the touchscreen display may provide other selectable elements including an element to change the settings of the AMD.
  • selecting element associated with settings change may activate a second screen that presents selectable elements associated with the setting user interface screens 2928 / 2932 / 2936 .
  • any of the setting user interface screens 2928 / 2932 / 2936 and/or parameter control element 2930 / 2934 / 2938 may require a passcode.
  • each one of the user interface screens 2928 / 2932 / 2936 and/or parameter control element 2930 / 2934 / 2938 may require a different passcode.
  • one or more user interface screens 2928 / 2932 / 2936 and/or parameter control element 2930 / 2934 / 2938 may not require a passcode.
  • access to the first user interface screen 2928 may require a first passcode
  • the access to the second user interface screen 2932 may require a second passcode
  • the access to the third user interface screen 2936 may not need a passcode.
  • all the user interface screens 2928 / 2932 / 2936 may be presented without the need for providing a passcode, but access to the one or more control elements in a control screen may require a passcode.
  • the user may select the second user interface screen 2932 without entering a passcode but in order to select one or more parameter control element 2934 on that screen, the user may need to enter one or more passcodes.
  • the passcode may be transmitted to the control and computing unit of the AMD where the setting change procedures 2912 (therapy change control procedure 2920 and wake control procedure 2922 ) determine the validity of the passcode by comparing it to the one or more stored user generated passwords 2926 or received or stored override passwords 2924 stored in a memory of the CCM.
  • FIG. 30 is a flow diagram illustrating an example method that may be used by an AMD to allow a user to change a setting of the AMD using a user generated passcode or an override passcode.
  • the AMD e.g., the wake action procedure in the CCM
  • a user interface may be activated.
  • the wake action may directly activate a setting change interface 3004 (e.g., a setting change screen presented on a touchscreen display).
  • a specific wake action may activate the setting change interface.
  • the AMD e.g., the setting change procedure in the CCM
  • may request a passcode e.g., by presenting a window to enter a passcode.
  • the AMD may determine whether the passcode matches a user generated passcode 3008 . If it is determined the passcode matches with a user generated passcode, the AMD may provide access 3010 to one or more control parameter elements associated with the received passcode. If the received passcode dose not match with any of the stored user generated passcode, the AMD may determine whether the passcode matches with an override passcode 3012 . If it is determined the passcode matches an override passcode stored in a memory of AMD or a memory of an authorized computing device, the AMD may provide access 3014 to one or more control parameter elements associated with the received override passcode. If it is determined the passcode does not match an override passcode, the AMD denies access 3016 to one or more passcode protected control elements.
  • the AMD e.g., the setting change procedure in the CCM
  • FIG. 31 is a flow diagram illustrating another example method that may be used by an AMD to allow a user to change a setting of the AMD using a user generated passcode or an override passcode.
  • the AMD e.g., the wake action procedure in the CCM
  • the AMD may provide a user interface (e.g., a touchscreen display) on which the user can provide a first gesture to activate a setting change interface or screen.
  • the AMD may activate a setting change interface 3106 or a screen.
  • the setting change interface or a screen may include one or more parameter control elements associated with one or more settings of the AMD.
  • the setting change interface or a screen may include one or more selectable elements each associated with a setting change screen (e.g., a screen provided on a touchscreen display) that may include one or more control parameters.
  • the AMD may determine whether the requested setting change is passcode protected or not 3110 .
  • the request for setting change may include selecting a parameter control element.
  • the request for setting change may include selecting a list of parameter control elements (e.g., included in a separate screen provided on a touchscreen display).
  • the AMD may permit access to one or more parameter control elements associated with the requested setting change 3112 .
  • the user may need to provide a second gesture on the user interface (e.g., touchscreen display) to confirm the changes made.
  • the AMD may change one or more settings 3118 according to the requested and confirmed changes.
  • the AMD may request a passcode 3120 via a passcode display (e.g., provided on a touchscreen display). In some examples, the request for the passcode may be presented on a display but the passcode may be received via a physical keypad.
  • the AMD may validate the passcode 3124 by comparing it with one or more user generated passcodes or an override passcode. If it is determined that the passcode matches with a user generated passcode or an override passcode, the AMD may activate 3126 one or more parameter control elements associated with the requested setting change. Subsequently, the AMD may receive a setting change via the selected control parameter element 3128 .
  • the user may need to provide a second gesture on the user interface (e.g., touchscreen display) to confi